Study of Phosphate Levels in Patients With Chronic Kidney Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

March 31, 2010

Conditions
Chronic Kidney Disease
Interventions
DRUG

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.

DRUG

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).

DRUG

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).

DRUG

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).

DRUG

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).

DRUG

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).

Trial Locations (60)

2

Klinika nefrologie VFN, Prague

26

Samodzielny Specjalistyczny, Siedlce

1011

Chuv Lausanne, Lausanne

1233

5th MHAT Sofia, Sofia

1309

SHATCVD - National Cardiology Hospital, Sofia

1407

"MHAT Tokuda Hospital Sofia", Sofia

1431

"UMHAT Alexandrovska Dialysis Clinic", Sofia

"UMHAT Sveti Ivan Rilski", Sofia

1784

"UMHAT Sveta Anna", Sofia

4003

MHAT Plovdiv, Plovdiv

5000

MDHAT Department of Haemodialysis and Nephrology, Veliko Tarnovo

5001

Kantonspital Aarau, Aarau

5300

MHAT, Gabrovo

7002

Department of Haemodialysis at MHAT, Rousse

8091

Universitatsspital Zurich, Zurich

10000

Klinicka bolnica, Zagreb

Poliklinika Sveti Duh II, Zagreb

10040

Klinicka bolnica Dubrava, Zagreb

11365

Nephrology Associates, Fresh Meadows

21000

Klinicki bolnicki centar Split, Split

23000

Opca bolnica Zadar, Zadar

31000

Klinicka bolnica Osijek, Osijek

33028

Pines Clinical Research, Pembroke Pines

37205

Nephrology Associates, Nashville

37404

Southeast Renal Research Institute, Chattanooga

43000

Opca bonica Bjelovar, Bjelovar

44106

University Hospitals / Case Medical Center, Cleveland

44263

Nephrologische Gemeinschaftspraxis und Dialysezentrum, Dortmund

44625

Marienhospital, Herne

47000

Opca bolnica Karlovac, Karlovac

48000

Opca bolnica, Koprivnica

51000

Klinicki bolnicki centar Rijeka, Rijeka

59231

Nemocnice Nove Mesto na Morave, Nove Město Na Morave

60200

Innef a.s. Hemodialyzancni stredisko, Brno

66160

University of Kansas Medical Center, Kansas City

74101

Nemocnice s poliklinikou v Novem Jicine, Nový Jičín

77099

Southwest Houston Research, Houston

80002

Western Nephrology & Metabolic Disease, Arvada

80220

Complete Renal Care, Denver

125284

GUZ City Clinical Hospital, Moscow

191104

Saint-Petersburg CUS City Mariinskaya Hospital, Saint Petersburg

195257

Saint-Petersburg GUZ City Clinical Hospital, Saint Petersburg

195607

GOU VPO, Saint Petersburg

196247

Saint-Petersburg GUZ City Hospital, Saint Petersburg

197089

GOU VPO, Saint Petersburg

198205

CUS City Hospital, Saint Petersburg

214001

MLPU Clinical City Hospital, Smolensk

410562

SC Renamed Nefrodial SRL, Oradea

420064

GOU VPO Kazan, Kazan'

540136

S.C. Avitum S.R.L, Târgu Mureş

630120

MUZ City Clinical Hospital, Novosibirsk

700503

Spitalul Clinic, Lasi

87-400

Niepubliczny Zaklad Opieki Zdrowotnej, Golub-Dobrzyń

40-027

Katedra i Klinika Nefrologii, Katowice

32-300

NZOZ Dializa, Olkusz

60-355

Katedra i Klinika Nefrologii, Poznan

98-200

Niepubliczny Zaklad Opieki Zdrowotnej, Sieradz

01-809

Centrum Dializy i Diagnostyki, Warsaw

022328

Institutul Clinic Fundeni, Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Vifor Pharma

INDUSTRY