NCT01464190 - A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients | Biotech Hunter

Enrollment

659

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

April 30, 2013

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

DRUG

PA21 (2.5 g tablet containing 500 mg iron)

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

DRUG

Sevelamer carbonate

Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Trial Locations (15)

3100

Medizinische Abteilung Nephrologie und Dialyse, Sankt Pölten

4000

CHU Sart Tilman, Liège

4001

St Augustines Hospital, Durban

11000

Zvezdara Clinical Medical Center, Belgrade

12045

KfH Nierenzentrum Berlin-Neukoelln, Berlin

51000

Clinical Hospital Center Rijeka, Rijeka

54058

Mykolayiv Regional Hospital, Mykolayiv

74101

Hospital with Polyclinic Novy Jicin, Nový Jičín

78215

San Antonio

550135

Dialmed Clinic SRL, Sibiu

650029

Kemerovo Regional hospital, Kemerovo

LV-4201

Vidzemes Hospital, Valmiera

LT-93220

"JSC Diaverum Clinics", Klaipėda

90-153

Teaching Hospital no.1 of Medical University of Lodz, Lodz

DT1 2JY

Dorset County Hospital NHS Foundation Trust, Dorset