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Clinical Trial Details

Trial ID: L0254
Source ID: NCT00824460
Associated Drug: 1.25 G Pa21 (250 Mg Iron)
Title: Study of Phosphate Levels in Patients With Chronic Kidney Disease
Acronym: PA21
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00824460/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: 1.25 g PA21 (250 mg iron)|DRUG: 5.0 g PA21 (1,000 mg iron)|DRUG: 7.5 g PA21 (1,500 mg iron)|DRUG: 10.0 g PA21 (2,000 mg iron)|DRUG: 12.5 g PA21 (2,500 mg iron)|DRUG: Sevelamer hydrochloride
Outcome Measures: Primary: Change From Baseline in Serum-phosphate Levels at the End of Treatment., 6 weeks after baseline | Secondary: Change From Baseline in Serum-phosphate Levels at Week 2, 2 weeks after baseline|Change From Baseline in Serum-phosphate Levels at Week 4, 4 weeks after baseline|Change From Baseline in Serum-phosphate Levels at Week 5, 5 weeks after baseline
Sponsor/Collaborators: Sponsor: Vifor Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 154
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-12
Completion Date: 2010-03
Results First Posted: 2014-04-01
Last Update Posted: 2014-04-01
Locations: Western Nephrology & Metabolic Disease, Arvada, Colorado, 80002, United States|Complete Renal Care, Denver, Colorado, 80220, United States|Pines Clinical Research, Pembroke Pines, Florida, 33028, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Nephrology Associates, Fresh Meadows, New York, 11365, United States|University Hospitals / Case Medical Center, Cleveland, Ohio, 44106, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37404, United States|Nephrology Associates, Nashville, Tennessee, 37205, United States|Southwest Houston Research, Houston, Texas, 77099, United States|MHAT, Gabrovo, 5300, Bulgaria|MHAT Plovdiv, Plovdiv, 4003, Bulgaria|Department of Haemodialysis at MHAT, Ruse, 7002, Bulgaria|5th MHAT Sofia, Sofia, 1233, Bulgaria|SHATCVD - National Cardiology Hospital, Sofia, 1309, Bulgaria|MHAT "Tokuda Hospital Sofia", Sofia, 1407, Bulgaria|UMHAT "Alexandrovska" Dialysis Clinic, Sofia, 1431, Bulgaria|UMHAT "Sveti Ivan Rilski", Sofia, 1431, Bulgaria|UMHAT "Sveta Anna", Sofia, 1784, Bulgaria|MDHAT Department of Haemodialysis and Nephrology, Veliko Tarnovo, 5000, Bulgaria|Opca bonica Bjelovar, Bjelovar, 43000, Croatia|Opca bolnica Karlovac, Karlovac, 47000, Croatia|Opca bolnica, Koprivnica, 48000, Croatia|Klinicka bolnica Osijek, Osijek, 31000, Croatia|Klinicki bolnicki centar Rijeka, Rijeka, 51000, Croatia|Klinicki bolnicki centar Split, Split, 21000, Croatia|Opca bolnica Zadar, Zadar, 23000, Croatia|Klinicka bolnica, Zagreb, 10000, Croatia|Poliklinika Sveti Duh II, Zagreb, 10000, Croatia|Klinicka bolnica Dubrava, Zagreb, 10040, Croatia|Innef a.s. Hemodialyzancni stredisko, Brno, 60200, Czech Republic|Nemocnice Nove Mesto na Morave, Nove Město na Morave, 59231, Czech Republic|Nemocnice s poliklinikou v Novem Jicine, Novy Jicin, 74101, Czech Republic|Klinika nefrologie VFN, Prague, 2, Czech Republic|Nephrologische Gemeinschaftspraxis und Dialysezentrum, Dortmund, 44263, Germany|Marienhospital, Herne, 44625, Germany|Niepubliczny Zaklad Opieki Zdrowotnej, Golub-Dobrzyń, 87-400, Poland|Katedra i Klinika Nefrologii, Katowice, 40-027, Poland|NZOZ Dializa, Olkusz, 32-300, Poland|Katedra i Klinika Nefrologii, Poznań, 60-355, Poland|Samodzielny Specjalistyczny, Siedlce, 26, Poland|Niepubliczny Zaklad Opieki Zdrowotnej, Sieradz, 98-200, Poland|Centrum Dializy i Diagnostyki, Warszawa, 01-809, Poland|Institutul Clinic Fundeni, Bucuresti, 022328, Romania|Spitalul Universitar de Urgenta Bucuresti, Bucuresti, 050098, Romania|Spitalul Clinic, Lasi, 700503, Romania|SC Renamed Nefrodial SRL, Oradea, 410562, Romania|S.C. Avitum S.R.L, Targu Mures, 540136, Romania|GOU VPO Kazan, Kazan, 420064, Russian Federation|GUZ City Clinical Hospital, Moscow, 125284, Russian Federation|MUZ City Clinical Hospital, Novosibirsk, 630120, Russian Federation|MLPU Clinical City Hospital, Smolensk, 214001, Russian Federation|Saint-Petersburg CUS City Mariinskaya Hospital, St. Petersburg, 191104, Russian Federation|Saint-Petersburg GUZ City Clinical Hospital, St. Petersburg, 195257, Russian Federation|GOU VPO, St. Petersburg, 195607, Russian Federation|Saint-Petersburg GUZ City Hospital, St. Petersburg, 196247, Russian Federation|GOU VPO, St. Petersburg, 197089, Russian Federation|CUS City Hospital, St.Petersburg, 198205, Russian Federation|Kantonspital Aarau, Aarau, 5001, Switzerland|Chuv Lausanne, Lausanne, 1011, Switzerland|Universitatsspital Zurich, Zürich, 8091, Switzerland
URL: https://clinicaltrials.gov/show/NCT00824460

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress