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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-09

Study Completion Date

2009-03-06

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitaxsentan

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

Group Type EXPERIMENTAL

Open

Intervention Type DRUG

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

Nifedipine

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

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Open

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

Intervention Type DRUG

Nifedipine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Sitaxsentan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No