Conditions: Diabetic Nephropathy Chronic Kidney Disease
Keywords: Type 2 Diabetic Nephropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 281
Healthy volunteers: no

Brief summary:
The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.

Detailed description:

Arms:
arm 1: One paricalcitol 1 mcg capsule and one matching placebo capsule per dose arm 2: Two paricalcitol 1 mcg capsules per dose arm 3: Two placebo capsules per dose

Interventions: intervention 1: Zemplar (paricalcitol ) capsules intervention 2: Zemplar (paricalcitol) capsules intervention 3: Placebo
Intervention descriptions: intervention 1: Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily) intervention 2: Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily) intervention 3: Group 1 - Placebo once daily (two placebo capsules once daily)

Protocol document: