Study of Phosphate Levels in Patients With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Inc.; Vifor Pharma
• Treatments: Iron; Sevelamer

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