Study of Phosphate Levels in Patients With Chronic Kidney Disease

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: 5.0 g PA21 (1,000 mg iron); Drug: 7.5 g PA21 (1,500 mg iron); Drug: 10.0 g PA21 (2,000 mg iron); Drug: 12.5 g PA21 (2,500 mg iron); Drug: 1.25 g PA21 (250 mg iron); Drug: Sevelamer hydrochloride

• Registration Number: NCT00824460
• Lead Sponsor: Vifor Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-16
• Primary Completion: 2009-10
• Study Completion: 2010-03
• Disposition First Submitted: 2012-07-23
• Disposition First Submitted QC: 2012-07-31
• Disposition First Posted: 2012-08-07
• Results First Submitted: 2013-12-20
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-03
• Last Update Submitted: 2014-03-03
• Results First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5.0 g PA21	5.0 g PA21 (1,000 mg iron)	-
7.5 g PA21	7.5 g PA21 (1,500 mg iron)	-
10.0 g PA21	10.0 g PA21 (2,000 mg iron)	-
12.5 g PA21	12.5 g PA21 (2,500 mg iron)	-
1.25 g PA21	1.25 g PA21 (250 mg iron)	-
Sevelamer hydrochloride - active control	Sevelamer hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Serum-phosphate Levels at the End of Treatment.	6 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Serum-phosphate Levels at Week 2	2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4	4 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 5	5 weeks after baseline

Trial Locations

Locations (56)

Western Nephrology & Metabolic Disease; 🇺🇸 Arvada, Colorado, United States

Complete Renal Care; 🇺🇸 Denver, Colorado, United States

Pines Clinical Research; 🇺🇸 Pembroke Pines, Florida, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Nephrology Associates; 🇺🇸 Nashville, Tennessee, United States

University Hospitals / Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Southeast Renal Research Institute; 🇺🇸 Chattanooga, Tennessee, United States

Southwest Houston Research; 🇺🇸 Houston, Texas, United States

MHAT; 🇧🇬 Gabrovo, Bulgaria

MHAT Plovdiv; 🇧🇬 Plovdiv, Bulgaria

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