Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects (FCRD01)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Nifedipine; Drug: Open; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810732

FCRD01 (Other Identifier)

B1321005

2006-002004-33 (EudraCT Number)

Details and patient eligibility

About

This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion criteria

• Required peritoneal dialysis or haemodialysis.
• Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 3 patient groups, including a placebo group

Sitaxsentan

Experimental group

Description:

Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)

Treatment:

Drug: Open

Nifedipine

Active Comparator group

Description:

Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)

Treatment:

Drug: Nifedipine

Placebo

Placebo Comparator group

Description:

Placebo for sitaxsentan, orally administered once daily (double blind arm)

Treatment:

Drug: Placebo