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`Published September 2004
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`

`

`KIDNEY INTERNATIONAL
`Volume 66, umber 3, eptember 2004
`
`Official Journal of the International Society of ephrology
`
`Le Journal Official de la ociete International de ephrologie
`
`Table of contents
`
`SATELLITE SYMPOSIUM
`RE AL BIOPSY REGISTRIES
`Berlin, Germany
`June 8, 2003
`
`Introduction F. Paolo Scheno and Loreto Gesualdo ..... . . . .. . .. . . .. . . . ...... . ..... . ......... . .. ........
`
`889
`
`The Jtalian experience of the na tional registry of renal biopsies. Loreto Gesualdo, Anna Maria Di
`Palma, Luigi Francesco Morrone, Giovanni Fabrizio Strippoli, and Francesco Paolo Scheno, on behalf
`of the ltalia11 lmnwnopathology Group, Italian Society of Nephrology..... . .... . . ................... . .
`The Danish Renal Biopsy Register. James Heaf. . ............................... .... . ... . ..... . .... . . . .
`
`Clinicopathologie correla tions of renal pathology in Spain. Francisco Rivera, Juan Ma11uel L6pez-
`G6mez, Rafael Perez-Carda, 011 behalf of the Spanish Registry of Glomerulonepltri1is . . . . . . . . . . . . . . .
`Epidemiologic data of primary glome rula r diseases in western France. Pierre Simon, Marie-Paule
`Ramee, Rehouni Boulahrouz, Corina Stanescu, Christophe Charasse, Kim Seng A11g, Fran~oise
`Leo11e11i, Gerard Cam, Eric Lame/le, Valerie Autuly, and Nathalie Rioux ..............................
`
`Signs and symptoms of thin basement membrane nephropathy: A prospective regional tudy on pri-
`mary glome rular di ease- The Limburg Re nal Registry. Pieter van Paas en, Peter J.C. van Breda
`Vriesman, 1/enk van Rie, and Jan Willem Cohen Tervaert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Outcome study of renal biopsy patients in Okinawa, Japan. Kunitoshi lseki, Fujihiko Miyasato,
`Hajime Uehara, Kiyoyuki Tok11ya11w, Shigeki Toma, Keizo Nishime, Shi11ichiro Yoshi, Yoshiki
`Shiohira, Takashi Oura, Masahiko Towwa, and Koshiro Fukiyama . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Epidemiologic data of renal diseases from a single unit in China: Analysis based on 13,519 renal
`biopsies. Lei-Shi Li and Zhi-Hong Liu ........... . .................. . .......... . . . . . ................. . ..
`
`PERSPECTIVES I RE AL MEDI I E
`Renal a ngiomyolipomata. John J. Biss/er and J. Chris Kingswood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`GE ETIC DISORDERS - DEVELOPME T
`A high prevalence of renal hypouricemia caused by inactive SLC22A12 in Japa nese. Naoharu l wai,
`Yukari Mino, Makoto Hosoyamada, aomi Tago, Yoshihiro Kokubo, and Hitoshi Endou.. . . . . . .....
`
`ln vivo expression of podocyte slit diaphragm-associated proteins in nephrotic patie nts with NPHS2
`mutation. Shao-Yu Zha11g, Arnaud Marlier, Olivier Gribouval, Thierry Gilbert, Laurence Heidel,
`Corinne Antignac, and Marie Claire Gubler .. . . . .. ......... . ... . .. . .. .... . . ... . .. ..... .. ...... ... . . .....
`
`890
`
`895
`
`898
`
`905
`
`909
`
`914
`
`920
`
`924
`
`935
`
`945
`
`Cover: Recombinant uteroglobin treatment prevents cellular and fibrocellular crescents formation in C57/BL6 mice (see Lee
`et al, Fig. 3C, p. 1064).
`
`

`

`Two novel ADAMTS13 gene mutations in thrombotic thrombocytopenic purpura/hemolytic-uremic
`syndro me (TIP/HUS). Christoph Licht, Ludwig Stapenhorst, Thorsten Simon, Ulrich Budde, Reinhard
`Schneppenheim, and Bernd Hoppe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Evaluation of mutation screening as a first line test for the diagnosis of the primary hyperoxalurias.
`Gill Rumsby, Emma Williams, and Marion Coulter-Mackie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Cyclic AMP promotes growth and secretion in human polycystic kidney epithelial cells. Franck A.
`Belibi, Gail Reif, Darren P. Wallace, Tamio Yamaguchi, Lincoln Olsen, Hong Li, George M. Helmkamp,
`Jr., and Jared 1. Grantham (see Editorial by Torres, p. 1283)........... . .. . .................... .. .......
`Mutations in the uromodulin gene decrease urinary excretion of Tamm-Horsfall protein. Anthony J.
`Bleyer, Thomas C. Hart, Zak Shihabi, Vicki Robins, and John R. Hoyer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Para pelvic kidney cysts: A distinguishing feature with high prevalence in Fabry disease. Markus Ries,
`Karen E. Bove Bellis, Peter Choyke, Jeffrey B. Kopp, Howard A. Austin Ill, Roscoe 0. Brady, and
`Raphael Schiffmann .................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`HORMONES - CYTOKINES - SIGNALING
`Pretreatment with EPO reduces the injury and dysfunction caused by ischemia/reperfusion in the
`mouse kidney in vivo. Nimesh S.A. Patel, Edward J. Sharpie:,; Salvatore Cuzzocrea, Prabal K. Chauerjee,
`Domenico Brilli, Muhammad M. Yaqoob, and Christoph Thiemermann. ... .... . . ... . . ... ..... ..... ...
`
`955
`
`959
`
`964
`
`974
`
`978
`
`983
`
`CELL BIOLOGY - IMMUNOLOGY - PATHOLOGY
`Renal proximal tubular cells acquire resistance to cell death stimuli in mice with hereditary tyrosinemia
`type l. Marjanka C. Luijerink, Ellen A. C M. van Beurden, llelga E.M. Malingre, Saskia M.M. Jacobs,
`Markus Grompe, Leo WJ. Klomp, Ruud Berger, and Inge E. T. van den Berg...... .... ................
`C-type natriuretic peptide as a podocyte hormone and modulation of its cGMP production by glucose
`and mechanical stress. Barbara Lewko, Nicole Endlich, Wilhelm Kriz, Jan Stepinski, and Karlhans
`Endlich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Autoantibodies to neutrophil cytoplasmic antigens (ANCA ) do not bind to polymorphonuclear neu(cid:173)
`trophils in blood. Bah.aa Abdel-Salam, Christo/ lking-Konert, Mallh.ias Schneider, Konrad Andrassy,
`and G. Maria Hansch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`R etinoic acid treatment protects MRUlpr lupus mice from the development of glomerular disease.
`Guillermo Perez de Lema, Francisco Javier Lucio-Cazana, Ana Molina, Bruno Luckow, Holger
`Sch.mid, Cor de Wit, Victoria Moreno-Manzano, Bernhard Banas, Francisco Mampaso, and Detlef
`Schlondorff..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Renal phenotype is exacerbated in Os and lprdoublc mutant mice. George Jarad, Sujata Lakhe-Reddy,
`Jeffrey Blatnik, Morgan Koepke, Shenaz Khan, M. Ashraf EI-Meanawy, Andrew S. O'Connor, John R.
`Sedor, and Jeffrey R. Schelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`The role of lymphocytes in the experimental progressive glomerulonephritis. Yohei lkezumi, Karsue
`Kanno, Tamaki Karasawa, Gi Dong Han, Yumi Ito, Hiroko Koike, Shinichi Toyabe, Makoto Uchiyama,
`Fujio Shimizu, and Hiroshi Kawachi ... . ............. . .......................... . .......................
`Wegener's granulomatosis is associated with organ-specific antiendothelial cell antibodies. Carolina
`Holmen, Marta Christensson, Erna Peuersson, Johan Brau, Piir Stjiirne, Azza Karrar, and Suchitra
`Sumitran-Holgersson ...... .... ......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Recombinant uteroglobin prevents the experimental crescentic glomerulonephritis. Dong-Sup L ee,
`Seung Hee Yang, Hyun Lee Kim, Kwon Wookloo, Chun Soo Lim, Dong-Wan Chae, Suhnggwon Kim,
`Jung Sang Lee, and Yon Su Kim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`990
`
`1001
`
`1009
`
`1018
`
`1029
`
`1036
`
`1049
`
`1061
`
`

`

`1068
`
`1076
`
`1082
`
`1090
`
`1099
`
`1107
`
`ION CHANNELS - MEMBRANE TRANSPORT - INTEGRATIVE PHYSIOLOGY
`The effccl o[ ~-~ubunil assembly on funcLion and localization of the colonic tt+ ,K+ -ATPase a-subunit.
`Jian Li, Juan Codina, Elizahelh Petroske, Mike.I. Werle, Mark C. Willingham, and Thomas D. Du Bose,
`Jr..........................................................................................................
`Racial differences in potassium disposal. An.nie Suh, Ernesi DeJesus, Karol Rosner; Edgar Lerma,
`William Yu, James B. Young, and Robert M. Rosa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Effecls of vitamin D compounds on renal and inteslinal Ca2+ transport proteins in 25-hydroxyvitamin
`D3-Ja-hydroxylase knockout mice. Joost G.J. Hoenderop, Ann.emiete WC.M. van der Kemp, Colleen
`M. Urben, Stephen A . Strugnell, and Rene J.M. Rindels (see Editorial by Goodman. p. 1286) .........
`VASCULAR BIOLOGY -HEMODYNAMICS-HYPERTENSION
`Calcium channel blockers, either amlodipine or mibefradil , ameliorate renal injury in experimental
`diabete . Guorong Ma, Terri J. Allen, Mark E. Cooper, and Zemin Cao . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Effecl o f advanced glycalion end-products on gene expression and synthesis ofTNF-a and endothelial
`nitric oxide synthase by endothelial cells. Gloria Rashid, Sydney Benchetrit, Dina Fishman, and Jacques
`Bernheim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`CLINICAL NEPHROLOGY - EPIDEMIOLOGY - CLINICAL TRIALS
`High expression of PKC-MAPK pathway mRNAs correlates with glomerular lesions in human diabetic
`nephropathy. Masao Toyoda, Daisuke Suzuki, Masashi Honma, Coro Uehara, Takako Sakai, Tomoya
`Umezono, and Hideto Sakai . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Early detection of acute renal fai lure by serum cyslatin C. Stefan Herger-Rosen1hal, Giinter Marggraf,
`Johannes Hiising, Frauke Goring, Frank Pietruck, Onn0Ja11sse11, Thomas Philipp, and Andreas K ribben 1115
`Gemfibrozil for secondary prevention of cardiovascular events in mild to moderate chronic renal
`insufficiency. Marcello Tonelli, Dorothea Collins, Sander Robins, Hanna Bloomfield, and Gary C.
`Curhan, for the Veterans' Affairs High-Density Lipoprotein lntervemion Trial ( VA-HJT) lnvestigaiors 1123
`Anemia and end-stage renal disease in patients with type 2 diabetes and ncphropathy. Anupama
`Mohan ram, Zhongxin Zhang, Shahnaz Shahinfar, William F. Keane, Barry M. Brenner, and R obert D.
`Toto............ . ....... .. . . .............. . ................................................... . ........... .
`Transferrin saturation with intravenous irons: An in vitro study. Rajiv Agarwal.... ....... . ... . .......
`The clinical epidemiology and course of the spectrum of renal diseases associated with HIV infection.
`Lynda Anne Szczech, Samir K. Gupta, Ramez Habash, Antonio Guasch, Robert Kalayjian, Rirhard
`Appel, Timothy A. Fields; Laura P Svetkey, Katherine /-1. Flanagan, Paul E. Klotman, and Jonathan A.
`Winston .... . .......... .. ...................................... . ........... .. ..............................
`Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: Two double-blind, randomized,
`placebo-controlled studies. Hassane Jzzedine, Jean Sebastien Hulot, Vincent Launay -Vacher, Patrick
`Marcellini, Stephanos J. Hadziyannis, Graham Currie, Carol L. Brosgart, Chris Westland, Sarah Arter-
`brun, and Gilbert Deray, for !he Adefovir Dipivoxil International 437 and 438 Study Groups. ... . .. . .
`Tamm-Horsfall protein is a critical renal defense factor protecting against calcium oxalate crystal
`formation. Lan Mo, Hong- Ying Huang, Xin-Hua Zhu, Ellen Shapiro, David L. Hasty, and Xue-Ru Wu 1159
`Low-molecular-weight AGEs are associated with GFR and anemia in patients with type 2 diabetes.
`Merlin C. Thomas, Con Tsalamandris, Richard Macisaac, Tanya Medley, Bronwyn Kingwe/1, Mark E.
`Cooper, and George Jerwns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Risk factors for renal replacement therapy in the Early Treatment Diabetic Retinopathy Study
`(ETDRS), Early Treatment Diabetic Retinopathy Study R eport No. 26. Michael Cusick, Emily Y.
`Chew, Byron 1/oogwerf, Elvira Agron, LieLing Wu, Anna Lindley, Frederick L. Ferris Ill, and The
`Early Trearment Diabetic Retinopathy Swdy Research Group ..........................................
`Improved survival in patients obtaining remission of nephrotic range albuminuria in diabetic ne phropa-
`thy. Peter Hovind, Lise Tamow, Peter Rossing, Bendix Carstensen, and Hans-I /enrik Parving . . . . . . . .
`
`1145
`
`l L31
`
`1139
`
`1153
`
`1167
`
`1173
`
`1180
`
`

`

`Duffy antigen recepto r and gene tic su ceptibility o f African Americans Lo acute rejectio n a nd delayed
`functio n. Kevin C. Mange, £ line Luning Prak, Malek Ka1110 11n, Yangz fw Du, N oah Goodman, Theodore
`Danoff, Tracey Hoy, Melissa N eivman, Marshall M. Joffe, and Harold/. Feldman .....................
`Iro n ucro e in hemodialysis patie nts: Sa fe ty o f re placeme nt and mainte nance regimens. George R.
`Aro noff, William M . Benne/I, Samuel Blumemhal, Chaim Chary ran, J. Phillip Pennell, Jo hn Reed,
`Marcos R o1hs1ein, Jam es S1rom , An1hony Wolfe, David Van Wyck , and Jerry Yee, f o r 1he United Sf{//es
`Iron Sucrose ( Venofer"') Clinical Trials G ro up .................... . ........ . ............................
`Idio pathic me mbranous nephropathy: D efinitio n and re levance o f a partial remissio n. S1ephan Troy-
`anov, Ca1herine A. Wall, ft1di1h A. Miller, Jam es W. Scholey, and Daniel C. Cal/ran, for 1he Toronto
`G lom erulo nephrilis Regis1ry G rot1p .....................................................................
`Interpre tatio n o f e rythro poie tin levels in patie nts with va rio us degrees of re nal ins ufficie ncy a nd
`ane mia. Thom as Fehr, Pe1er Ammann, Daniela G arzoni, Wolfgang Korie, Waller Fierz, I fan s Rickli,
`and Rudolf P Wii1hrich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`DIALYSTS - TRA SPLA TATIO
`Hemodialysi -associated hypo te nsio n as a n inde pe ndent risk facto r fo r two-year mo rtality in hemodia l-
`ysis pa tie nts. Ta1s11ya Shoji, Yoshiharu Tsubak ihara, M asamilsu Fujii, and Eny u Imai . . . . . . . . . . . . . . . .
`Dia lysate magnesium level a nd blood pressure. John Kyriazis, Kons1an1ina Kalogeropoulot1, Leonid a.1
`Bilirakis, Nikolaos Smirniot1dis, Vasilios Pikounis, Dimi1rios S1a111{//iadis, and Eka1erini Liolia .......
`Clinical conseque nces o f a n individua li:,ed di alysate sodium pre cripti on in he modialy is patie nts.
`Fla vio M. de Paula, Aldo J. Peixo10, Luciano V. Pi1110, Da vid Do rigo, Pedro J. M. Pa1ricio, and Sergio
`FF. Samos................................................................................................
`A systematic revie w of sevela me r in E RD and an analysis of its pote ntia l eco no mic impact in Canad a
`and the United States. Braden Manns, Lesley S1evens, Dana Miskulin, William F. Diven, Jr., Wolfgang
`C. Win kelmayer, and Marcello Tonelli.......................................................... . ........
`Protective effects of fTY 720 o n chronic a llograft ne phropa thy by reducing late lymph ocytic infiltra-
`tio n. Minght1i Wang, Shany ing Liu, Neng1ai Ouyang, Envei Song, Jens Lt11z, and Uwe lfeem ann .. .. .
`Lo ng-te rm expo ure to new perito neal dia lysis solutions: Effects o n the pe rit oneal me mbra ne. Sisk a
`M or1ier, Dirk Faic1, Casper G. Sclwlk wijk , Norben II. L a111eire, and An S. D e Vriese . . . . . . . . . . . . . . . . .
`Vector length as a proxy fo r the adequacy o f ultrafiltratio n in he modialysis. Luana Pillon, A nlonio
`Piccoli, Edmt1nd G. L owrie, J. Michael L azarus, and G lenn M . Cher/o w...............................
`
`TECH ICAL OTE
`Free-breathing rena l MR angiography with steady-state free-precessio n (SSFP) and slab-selective spin
`inversio n: Initia l results. Marcus Ka1oh, A rno Buecker, Ma11hias S1uber, R olf W. Giinlher, and £/mar
`Spt1enlrup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Enzyme replacement therapy administe red during he m odia lysis in patients with Fabry di sease. M ark 11s
`Kosch, H ans-Georg Koch, Joao Paulo Oliveira, Carlos So ares, Francesco Bianco, Frank Bre11ning, Ase
`Krogh R asmussen, and Roland M . Schaefer.......... . ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`EDITORIALS
`Cyclic AMP, at the hub of the cystic cycle. Vicem e £ . Torres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`The flavors o f vitamin D : Tasting the molecular mecha nisms. William G. G oodman . . . . . . . . . . . . . . . . . .
`
`LETTERS TO THE EDITOR
`Thera py o f Fa bry disease. Julia Kleinen , Anna-Chrisline I latisser, M a11hias Lo renz, Mant1ela Fo dinger,
`and Gere Swuler-Plassmann. . . ..........................................................................
`The sea rch for maturity .... Lt1c Tt1rmel-R odrig11es .....................................................
`
`1187
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`1193
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`1199
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`1206
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`1212
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`122 1
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`123:.
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`123t,
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`124b
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`1257
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`1266
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`127-
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`127
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`128~
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`J 28u
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`128~
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`12b)
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`Differe ntial diagnosis between X-linked Alport syndrome a nd thin baseme nt membrane nephropathy.
`Gianfranco Riu.oni and Laura Massella .. .. . . . . . .. .. .. .. .. .. .. .. . . . . .. . . . . .. . . .. . .. . .. . . . . . .. . . . . . . . . . .
`
`Diagnosis of Alport synd rome. Cliffo rd E. Kash/an . .. .. . .. . .. . . . . . . .. . .. . .. . .. .. .. .. . . . . . .. . . .. .. .. .. .
`
`Dia lysis dose and gender: A different hypothesi . E dmund C. Lowrie. Norma Ofsthun, and Zhengsheng
`Li..................... .... .......... .................. . . .................... ............ . .................
`
`-acetylcyste ine-Enough is enough ? Hendrik Koller and
`Preventio n o f acute re nal fa ilure with
`Alexander R. Rosenkran::.............. . .............................. .. . . . . . .. .. . .. . . .. . . . . .. . . . . . . .. .. . .
`
`1289
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`1290
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`1291
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`1292
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`NEPHROLOGY FORUM
`ll1e changing face or childhood nephrotic syndrome. Russell Chesney.. .............. . ...... . ... . ... ..
`
`1294
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`INTERNATIO AL SOCIETY OF NEPHROLOGY
`Membe rship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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`1303
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`Meeting Anno unceme nts .. . .. . .. . .. . .. .. . . .. .. . .. .. . . . .. . .. .. .. . .. . .. . . • . .. .. .. . . . . . . .. . . .. . .. . . . . .. . . .
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`1303
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`Books R eceived . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`Errata .. .. . . . .. .. ... . . ... . .. .. .. . ... ... . ... .... .......... .... .. .. .. . ..... . ... . . . . . . . .. . .. . . .. ... . . . . .. .. . .
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`1304
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`/11s1ruc1io11s for Awhors 011 page xvii-xvi ii
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`

`

`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`Kidney International, Vol. 66 (2004), pp. I /93-/ /98
`
`Iron sucrose in hemodialysis patients: Safety of replacement and
`maintenance regimens
`
`GEORGE R. ARONOFF, WILLIAM M. BENNETT, SAMUEL BLUMENTHAL, CHAIM CHARYTAN,
`J. PHILLIP PENNELL, JOHN REED, MARCOS ROTHSTEIN, JAMES STROM, ANTHONY WOLFE,
`DAVID VANWYCK, and JERRY YEE, FOR THE UNITED STATES IRON SUCROSE (VENOFER®) CLINICAL
`TRIALS GROUP
`
`University of Louisville School of Medicine, Louisville, Kentucky; Northwest Renal Clinic, Portland, Oregon; Medical College of
`Wisconsin, Milwaukee, Wisconsin; New York Hospital of Queens, Flushing, New York ; University of Miami School of Medicine,
`Miami, Florida; Nephrology Associates, Columbus, Mississippi; Barnes-Jewish Dialysis Center, St. Louis, Missouri; Caritas St.
`Elizaberh 's Medical Cenrer, Bosron, Massachusetrs; Renal Care Cenrer, San Luis Obispo, California; University of Arizona College
`of Medicine, Tucson, Arizona; and Henry Ford Hospital, Detroit, Michigan
`
`Iron sucrose in hemodialysis patients: Safety of replacement
`and maintenance regimens.
`Backgro,md. Parenteral iron replacement and maintenance
`are frequently required in hemodialysis patients. However, se(cid:173)
`rious adverse events have been reported after single doses of
`some intravenous iron products. This multicenter phase IV clin(cid:173)
`ical trial examined the safety of iron sucrose for the treatment
`of iron deficiency and for the maintenance of iron sufficiency in
`hemodialysis patients.
`Methods. In this safety study, iron sucrose was given in two
`dosing regimens. Iron deficient patients were treated with intra(cid:173)
`venous iron sucrose, I 00 mg, during 10 consecutive hemodialy(cid:173)
`sis sessions (replacement regimen). Iron replete patients were
`given iron sucrose, 100 mg intravenous (iv) over 5 minutes,
`weekly for 10 weeks (maintenance regimen). At the end of each
`10-dose cycle, iron status was reassessed, and dosing during the
`subsequent cycle was based on the adequacy of iron stores as
`per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines.
`With each dosing regimen , adverse events, if any, were recorded
`and described.
`Results. Six hundred and sixty-five hemodialysis patients, in(cid:173)
`cluding 80 who had experienced previous intolerance to other
`parenteral iron preparations, received a total of 8583 doses of
`iron sucrose. One hundred eighty-eight patients received more
`than one iv iron cycle (replacement, maintenance, or both).
`There were no serious or life-threatening drug-related adverse
`events.
`Conclusion . Iron sucrose is safe when given as treatment for
`iron deficiency or for maintenance of iron stores.
`
`Hemodialysis patients require both iron replacement
`and iron maintenance therapy to optimize management
`of anemia. Because oral iron supplements are relatively
`ineffective in correcting iron deficiency and maintaining
`iron balance, clinical practice guidelines recommend ad(cid:173)
`ministration of intravenous iron [3].
`
`Key words: iron sucrose, hemodialysis , an emi a, iron defici ency, safety.
`
`© 2004 by the International Society of Nephrology
`
`Though intravenous iron products are effective in the
`treatment of the anemia of chronic kidney disease (CKD)
`[6, 17], serious adverse drug events have been reported
`with even single doses of some of these products [10, 16].
`Iron sucrose has been used worldwide for more than 50
`years [5]. Two multicenter studies have been performed
`in the United States to evaluate the safety and efficacy
`of iron sucrose injection in the treatment of dialysis(cid:173)
`associated anemia [6, 19]. No serious drug-related ad(cid:173)
`verse events or severe hypersensitivity reactions were
`seen in either study. However, both studies were rela(cid:173)
`tively small, and both lacked information on maintenance
`iron regimens. To date, no large-scale, multicenter, mul(cid:173)
`tidose study has been reported to examine the safety of
`any intravenous iron compound given as repeated doses
`by multiple dosing regimens in a patient-management
`environment.
`The current study was undertaken to examine the
`safety of iron sucrose under usual clinical situations. Be(cid:173)
`cause anemia management commonly includes both iron
`maintenance and iron replacement therapy, we sought to
`obtain information on iron safety using both iron dosing
`regimens. Accordingly, iron status was defined according
`to K/DOQI guidelines [3]. If the patient was iron defi(cid:173)
`cient, the investigator used an iron replacement regimen.
`[f the patient was iron replete, a maintenance regimen
`was used. Patients could receive multiple dosing cycles
`and either dosing regimen, depending upon their current
`iron status.
`
`METHODS
`Study design
`This was a multicenter, open label, phase IV clin(cid:173)
`ical trial in hemodialysis patients who required both
`
`ll93
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`Aronoff et al: Iron sucrose safety
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