Study of Phosphate Levels in Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease
- Interventions
- 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: 1.25 g PA21 (250 mg iron)
- Registration Number
- NCT00824460
- Lead Sponsor
- Vifor Pharma
- Brief Summary
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- ≥ 18 years of age,
- 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
Main
- Uncontrolled hyperphosphatemia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5.0 g PA21 5.0 g PA21 (1,000 mg iron) - 7.5 g PA21 7.5 g PA21 (1,500 mg iron) - 10.0 g PA21 10.0 g PA21 (2,000 mg iron) - 12.5 g PA21 12.5 g PA21 (2,500 mg iron) - 1.25 g PA21 1.25 g PA21 (250 mg iron) - Sevelamer hydrochloride - active control Sevelamer hydrochloride -
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum-phosphate Levels at the End of Treatment. 6 weeks after baseline
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (56)
UMHAT "Sveti Ivan Rilski"
🇧🇬Sofia, Bulgaria
MDHAT Department of Haemodialysis and Nephrology
🇧🇬Veliko Tarnovo, Bulgaria
Innef a.s. Hemodialyzancni stredisko
🇨🇿Brno, Czech Republic
UMHAT "Alexandrovska" Dialysis Clinic
🇧🇬Sofia, Bulgaria
Nemocnice s poliklinikou v Novem Jicine
🇨🇿Novy Jicin, Czech Republic
Katedra i Klinika Nefrologii
🇵🇱Poznań, Poland
NZOZ Dializa
🇵🇱Olkusz, Poland
Spitalul Clinic
🇷🇴Lasi, Romania
S.C. Avitum S.R.L
🇷🇴Targu Mures, Romania
Saint-Petersburg CUS City Mariinskaya Hospital
🇷🇺St. Petersburg, Russian Federation
CUS City Hospital
🇷🇺St.Petersburg, Russian Federation
Kantonspital Aarau
🇨🇭Aarau, Switzerland
Saint-Petersburg GUZ City Clinical Hospital
🇷🇺St. Petersburg, Russian Federation
Universitatsspital Zurich
🇨🇭Zürich, Switzerland
Nephrologische Gemeinschaftspraxis und Dialysezentrum
🇩🇪Dortmund, Germany
Samodzielny Specjalistyczny
🇵🇱Siedlce, Poland
MHAT
🇧🇬Gabrovo, Bulgaria
SHATCVD - National Cardiology Hospital
🇧🇬Sofia, Bulgaria
Western Nephrology & Metabolic Disease
🇺🇸Arvada, Colorado, United States
Opca bonica Bjelovar
🇭🇷Bjelovar, Croatia
MHAT Plovdiv
🇧🇬Plovdiv, Bulgaria
Klinicka bolnica Dubrava
🇭🇷Zagreb, Croatia
GOU VPO
🇷🇺St. Petersburg, Russian Federation
Chuv Lausanne
🇨🇭Lausanne, Switzerland
Southwest Houston Research
🇺🇸Houston, Texas, United States
Pines Clinical Research
🇺🇸Pembroke Pines, Florida, United States
University Hospitals / Case Medical Center
🇺🇸Cleveland, Ohio, United States
Southeast Renal Research Institute
🇺🇸Chattanooga, Tennessee, United States
Complete Renal Care
🇺🇸Denver, Colorado, United States
Nephrology Associates
🇺🇸Nashville, Tennessee, United States
Department of Haemodialysis at MHAT
🇧🇬Ruse, Bulgaria
5th MHAT Sofia
🇧🇬Sofia, Bulgaria
UMHAT "Sveta Anna"
🇧🇬Sofia, Bulgaria
MHAT "Tokuda Hospital Sofia"
🇧🇬Sofia, Bulgaria
Opca bolnica Karlovac
🇭🇷Karlovac, Croatia
Opca bolnica
🇭🇷Koprivnica, Croatia
Klinicka bolnica Osijek
🇭🇷Osijek, Croatia
Klinicki bolnicki centar Split
🇭🇷Split, Croatia
Klinicki bolnicki centar Rijeka
🇭🇷Rijeka, Croatia
Klinicka bolnica
🇭🇷Zagreb, Croatia
Opca bolnica Zadar
🇭🇷Zadar, Croatia
Poliklinika Sveti Duh II
🇭🇷Zagreb, Croatia
Nemocnice Nove Mesto na Morave
🇨🇿Nove Město na Morave, Czech Republic
Klinika nefrologie VFN
🇨🇿Prague, Czech Republic
Marienhospital
🇩🇪Herne, Germany
Niepubliczny Zaklad Opieki Zdrowotnej
🇵🇱Sieradz, Poland
Centrum Dializy i Diagnostyki
🇵🇱Warszawa, Poland
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucuresti, Romania
SC Renamed Nefrodial SRL
🇷🇴Oradea, Romania
MLPU Clinical City Hospital
🇷🇺Smolensk, Russian Federation
GOU VPO Kazan
🇷🇺Kazan, Russian Federation
GUZ City Clinical Hospital
🇷🇺Moscow, Russian Federation
MUZ City Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Saint-Petersburg GUZ City Hospital
🇷🇺St. Petersburg, Russian Federation
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States