Study of Phosphate Levels in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— PA21  

Official title:

An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824460
• Other study ID #: PA-CL-03A
• Secondary ID: 75610
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: March 3, 2014
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2014
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• = 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 Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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).

Locations

Country	Name	City	State
Bulgaria	MHAT	Gabrovo
Bulgaria	MHAT Plovdiv	Plovdiv
Bulgaria	Department of Haemodialysis at MHAT	Ruse
Bulgaria	5th MHAT Sofia	Sofia
Bulgaria	MHAT "Tokuda Hospital Sofia"	Sofia
Bulgaria	SHATCVD - National Cardiology Hospital	Sofia
Bulgaria	UMHAT "Alexandrovska" Dialysis Clinic	Sofia
Bulgaria	UMHAT "Sveta Anna"	Sofia
Bulgaria	UMHAT "Sveti Ivan Rilski"	Sofia
Bulgaria	MDHAT Department of Haemodialysis and Nephrology	Veliko Tarnovo
Croatia	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	Klinicka bolnica Dubrava	Zagreb
Croatia	Poliklinika Sveti Duh II	Zagreb
Czech Republic	Innef a.s. Hemodialyzancni stredisko	Brno
Czech Republic	Nemocnice Nove Mesto na Morave	Nove Mesto na Morave
Czech Republic	Nemocnice s poliklinikou v Novem Jicine	Novy Jicin
Czech Republic	Klinika nefrologie VFN	Prague
Germany	Nephrologische Gemeinschaftspraxis und Dialysezentrum	Dortmund
Germany	Marienhospital	Herne
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Golub-Dobrzyn
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	Warszawa
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Clinic	Lasi
Romania	SC Renamed Nefrodial SRL	Oradea
Romania	S.C. Avitum S.R.L	Targu Mures
Russian Federation	GOU VPO Kazan	Kazan
Russian Federation	GUZ City Clinical Hospital	Moscow
Russian Federation	MUZ City Clinical Hospital	Novosibirsk
Russian Federation	MLPU Clinical City Hospital	Smolensk
Russian Federation	GOU VPO	St. Petersburg
Russian Federation	GOU VPO	St. Petersburg
Russian Federation	Saint-Petersburg CUS City Mariinskaya Hospital	St. Petersburg
Russian Federation	Saint-Petersburg GUZ City Clinical Hospital	St. Petersburg
Russian Federation	Saint-Petersburg GUZ City Hospital	St. Petersburg
Russian Federation	CUS City Hospital	St.Petersburg
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Chuv Lausanne	Lausanne
Switzerland	Universitatsspital Zurich	Zürich
United States	Western Nephrology & Metabolic Disease	Arvada	Colorado
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	University Hospitals / Case Medical Center	Cleveland	Ohio
United States	Complete Renal Care	Denver	Colorado
United States	Nephrology Associates	Fresh Meadows	New York
United States	Southwest Houston Research	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Nephrology Associates	Nashville	Tennessee
United States	Pines Clinical Research	Pembroke Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vifor Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Czech Republic,  Germany,  Poland,  Romania,  Russian Federation,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum-phosphate Levels at the End of Treatment.		6 weeks after baseline	No
Secondary	Change From Baseline in Serum-phosphate Levels at Week 2		2 weeks after baseline	No
Secondary	Change From Baseline in Serum-phosphate Levels at Week 4		4 weeks after baseline	No
Secondary	Change From Baseline in Serum-phosphate Levels at Week 5		5 weeks after baseline	No