Study of Phosphate Levels in Patients With Chronic Kidney Disease
NCT ID: NCT00824460
Last Updated: 2014-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2008-12-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1.25 g PA21
1.25 g PA21 (250 mg iron)
Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
5.0 g PA21
5.0 g PA21 (1,000 mg iron)
Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
7.5 g PA21
7.5 g PA21 (1,500 mg iron)
Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
10.0 g PA21
10.0 g PA21 (2,000 mg iron)
Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
12.5 g PA21
12.5 g PA21 (2,500 mg iron)
Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Sevelamer hydrochloride - active control
Sevelamer hydrochloride
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Interventions
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1.25 g PA21 (250 mg iron)
Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
5.0 g PA21 (1,000 mg iron)
Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
7.5 g PA21 (1,500 mg iron)
Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
10.0 g PA21 (2,000 mg iron)
Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
12.5 g PA21 (2,500 mg iron)
Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Sevelamer hydrochloride
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Eligibility Criteria
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Inclusion Criteria
* Receiving stable maintenance hemodialysis 3 times a week
* On restricted phosphate diet at screening and throughout study
* Receiving stable dose of phosphate binder for at least 1 month
* Serum phosphate levels \>1.78 mmol/L
Exclusion Criteria
* Hypercalcemia at screening or during washout
* Serum calcium \< 1.9 mmol/L (\<7.6 mg/dL)
* Severe hyperparathyroidism (iPTH levels \>600 ng/L)
* Pregnancy or lactation
* Iron deficiency anemia
* History of hemochromatosis or ferritin \>800 mg/L,
* Hepatitis B, hepatitis C or other significant concurrent liver disorders
* Known positivity to HIV
* Use of oral iron preparations 1 month before screening,
* Serious medical condition or uncontrolled systemic disease
18 Years
ALL
No
Sponsors
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Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Rudolf P Wutrich, MD
Role: PRINCIPAL_INVESTIGATOR
Unafilliated
Locations
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Western Nephrology & Metabolic Disease
Arvada, Colorado, United States
Complete Renal Care
Denver, Colorado, United States
Pines Clinical Research
Pembroke Pines, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Nephrology Associates
Fresh Meadows, New York, United States
University Hospitals / Case Medical Center
Cleveland, Ohio, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Nephrology Associates
Nashville, Tennessee, United States
Southwest Houston Research
Houston, Texas, United States
MHAT
Gabrovo, , Bulgaria
MHAT Plovdiv
Plovdiv, , Bulgaria
Department of Haemodialysis at MHAT
Rousse, , Bulgaria
5th MHAT Sofia
Sofia, , Bulgaria
SHATCVD - National Cardiology Hospital
Sofia, , Bulgaria
MHAT "Tokuda Hospital Sofia"
Sofia, , Bulgaria
UMHAT "Alexandrovska" Dialysis Clinic
Sofia, , Bulgaria
UMHAT "Sveti Ivan Rilski"
Sofia, , Bulgaria
UMHAT "Sveta Anna"
Sofia, , Bulgaria
MDHAT Department of Haemodialysis and Nephrology
Veliko Tarnovo, , Bulgaria
Opca bonica Bjelovar
Bjelovar, , Croatia
Opca bolnica Karlovac
Karlovac, , Croatia
Opca bolnica
Koprivnica, , Croatia
Klinicka bolnica Osijek
Osijek, , Croatia
Klinicki bolnicki centar Rijeka
Rijeka, , Croatia
Klinicki bolnicki centar Split
Split, , Croatia
Opca bolnica Zadar
Zadar, , Croatia
Klinicka bolnica
Zagreb, , Croatia
Poliklinika Sveti Duh II
Zagreb, , Croatia
Klinicka bolnica Dubrava
Zagreb, , Croatia
Innef a.s. Hemodialyzancni stredisko
Brno, , Czechia
Nemocnice Nove Mesto na Morave
Nove Město Na Morave, , Czechia
Nemocnice s poliklinikou v Novem Jicine
Nový Jičín, , Czechia
Klinika nefrologie VFN
Prague, , Czechia
Nephrologische Gemeinschaftspraxis und Dialysezentrum
Dortmund, , Germany
Marienhospital
Herne, , Germany
Niepubliczny Zaklad Opieki Zdrowotnej
Golub-Dobrzyń, , Poland
Katedra i Klinika Nefrologii
Katowice, , Poland
NZOZ Dializa
Olkusz, , Poland
Katedra i Klinika Nefrologii
Poznan, , Poland
Samodzielny Specjalistyczny
Siedlce, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Sieradz, , Poland
Centrum Dializy i Diagnostyki
Warsaw, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, , Romania
Spitalul Clinic
Lasi, , Romania
SC Renamed Nefrodial SRL
Oradea, , Romania
S.C. Avitum S.R.L
Târgu Mureş, , Romania
GOU VPO Kazan
Kazan', , Russia
GUZ City Clinical Hospital
Moscow, , Russia
MUZ City Clinical Hospital
Novosibirsk, , Russia
Saint-Petersburg CUS City Mariinskaya Hospital
Saint Petersburg, , Russia
Saint-Petersburg GUZ City Clinical Hospital
Saint Petersburg, , Russia
GOU VPO
Saint Petersburg, , Russia
Saint-Petersburg GUZ City Hospital
Saint Petersburg, , Russia
GOU VPO
Saint Petersburg, , Russia
CUS City Hospital
Saint Petersburg, , Russia
MLPU Clinical City Hospital
Smolensk, , Russia
Kantonspital Aarau
Aarau, , Switzerland
Chuv Lausanne
Lausanne, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Other Identifiers
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75610
Identifier Type: -
Identifier Source: secondary_id
PA-CL-03A
Identifier Type: -
Identifier Source: org_study_id
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