Study of Phosphate Levels in Patients With Chronic Kidney Disease - Full Text View

Sponsored by:	Vifor Pharma
Information provided by:	Vifor Pharma
ClinicalTrials.gov Identifier:	NCT00824460

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: PA21 Drug: Renagel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by Vifor Pharma:

Primary Outcome Measures:

Change from baseline in serum-phosphate levels at the end of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in serum-phosphate levels at each time point (apart from end of treatment) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	252
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.25 g PA21: Experimental	Drug: PA21 Comparison of different doses of PA21
5g PA21: Experimental	Drug: PA21 Comparison of different doses of PA21
7.5 g of PA21: Experimental	Drug: PA21 Comparison of different doses of PA21
10g of PA21: Experimental	Drug: PA21 Comparison of different doses of PA21
12.5g PA21: Experimental	Drug: PA21 Comparison of different doses of PA21
active control: Experimental	Drug: Renagel patients will receive 4.8 g

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824460

Contacts

Contact: Sylvain Gaillard

sylvain.gaillard@viforpharma.com

Show 64 Study Locations

Sponsors and Collaborators

Vifor Pharma

Investigators

Principal Investigator:

Prof. Rudolf P Wutrich, MD

Unafilliated

More Information

No publications provided

Responsible Party:	Vifor Pharma ( Sylvain Gaillard )
Study ID Numbers:	PA-CL-03A, 75610
Study First Received:	January 9, 2009
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00824460 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vifor Pharma:

Hemodialysis

Study placed in the following topic categories:

Sevelamer
Signs and Symptoms
Renal Insufficiency
Urologic Diseases

Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 04, 2009