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The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors

NCT00421733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2012-01-20

Study results available
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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.

Conditions

Interventions

DRUG

Zemplar (paricalcitol ) capsules

Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)

DRUG

Zemplar (paricalcitol) capsules

Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)

DRUG

Placebo

Group 1 - Placebo once daily (two placebo capsules once daily)

Sponsors & Collaborators

Principal Investigators

  • Dennis Andress, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Spain
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421733 on ClinicalTrials.gov