Study of Phosphate Levels in Patients With Chronic Kidney Disease (PA21)

Vifor

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: 5.0 g PA21 (1,000 mg iron); Drug: 12.5 g PA21 (2,500 mg iron); Drug: Sevelamer hydrochloride; Drug: 10.0 g PA21 (2,000 mg iron); Drug: 1.25 g PA21 (250 mg iron); Drug: 7.5 g PA21 (1,500 mg iron)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824460

75610

PA-CL-03A

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 6 patient groups

1.25 g PA21

Experimental group

Treatment:

Drug: 1.25 g PA21 (250 mg iron)

5.0 g PA21

Experimental group

Treatment:

Drug: 5.0 g PA21 (1,000 mg iron)

7.5 g PA21

Experimental group

Treatment:

Drug: 7.5 g PA21 (1,500 mg iron)

10.0 g PA21

Experimental group

Treatment:

Drug: 10.0 g PA21 (2,000 mg iron)

12.5 g PA21

Experimental group

Treatment:

Drug: 12.5 g PA21 (2,500 mg iron)

Sevelamer hydrochloride - active control

Experimental group

Treatment:

Drug: Sevelamer hydrochloride