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Nifedipine · 1 trial · 1 indication
Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.
| Arm | Type | Description |
|---|---|---|
| Sitaxsentan | EXPERIMENTAL | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
| Nifedipine | ACTIVE_COMPARATOR | Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm) |
| Placebo | PLACEBO_COMPARATOR | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
| Name | Type | Description |
|---|---|---|
| Open | DRUG | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
| Nifedipine | DRUG | Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm) |
| Placebo | DRUG | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
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 n...
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Nifedipine is being studied in chronic kidney disease as a calcium channel blocker, with a Phase 2 trial evaluating its effects on proteinuria, 24-hour blood pressure, and arterial stiffness. It is a small molecule developed by Pfizer, Inc. (PFE). The trial has been completed.
Nifedipine targets the calcium channels CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker of these channels, which are involved in calcium transport. This mechanism underlies its use in cardiovascular and kidney-related conditions.
Nifedipine is developed by Pfizer, Inc., which trades under the ticker PFE. The company is responsible for the clinical development of the drug in chronic kidney disease.
Nifedipine is in Phase 2 development for chronic kidney disease. The only listed trial is a completed Phase 2 study. It is an investigational use in this indication and has not been approved for chronic kidney disease.
Nifedipine has been studied in one completed Phase 2 trial, NCT00810732, titled Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects. The trial enrolled 27 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.