NCT01324128 - A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients | Biotech Hunter

Enrollment

1,059

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

April 30, 2012

Study Completion Date

October 31, 2012

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

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

DRUG

PA21-1 (1.25 g tablet containing 250 mg iron)

Low dose comparator (1.25 g/day)

Trial Locations (15)

1500

Lakeview Hospital, Benoni

3100

LKH St. Polten, Sankt Pölten

4000

CHU Sart Tilman, Liège

11000

Zvezdara Clinical Medical Center, Belgrade

12045

KfH Nierenzentrum Berlin-Neukoelln, Berlin

35601

Dialysis Centre Fresenius Medical Care, Sokolov

51000

Clinical Hospital Center Rijeka, Rijeka

54058

Mykolayiv Regional Hospital, Mykolayiv

78215

San Antonio

191104

City Mariinsky Hospital, Saint Petersburg

550135

Dialmed Clinic SRL, Sibiu

LV-4201

Vidzemes Hospital, Valmiera

LT-08661

Vilnius University Hospital Santariskiu Clinics, Vilnius

90-153

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

DT1 2JY

Dorset County Hospital NHS Foundation Trust, Dorset