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NCT00421733 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chronic Kidney Disease and Diabetic Nephropathy, sponsored by Abbott.

Completed
Registry status
Phase 2
Development phase
281
Enrollment target
20
Study locations

NCT00421733: Completed Phase 2 study of Chronic Kidney Disease and Diabetic Nephropathy, sponsored by Abbott.

NCT00421733 is a Phase 2 study of Chronic Kidney Disease and Diabetic Nephropathy that has completed, run by Abbott. The registered enrollment target is 281 participants, below the 3,204-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00421733, a Phase 2 study of Chronic Kidney Disease and Diabetic Nephropathy, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 2
Development phase
281 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.

Interventions

  • DRUG Placebo
  • DRUG Zemplar (paricalcitol ) capsules
  • DRUG Zemplar (paricalcitol) capsules

Study Locations (20)

Florida

  • Site Reference ID/Investigator# 853 - Hudson
  • Site Reference ID/Investigator# 867 - Lauderdale Lakes
  • Site Reference ID/Investigator# 857 - Pembroke Pines
  • Site Reference ID/Investigator# 8901 - West Palm Beach

North Carolina

  • Site Reference ID/Investigator# 866 - Charlotte
  • Site Reference ID/Investigator# 8039 - Greenville
  • Site Reference ID/Investigator# 8053 - Morehead City

California

  • Site Reference ID/Investigator# 864 - Fountain Valley
  • Site Reference ID/Investigator# 7291 - Yuba City

Illinois

  • Site Reference ID/Investigator# 2531 - Chicago
  • Site Reference ID/Investigator# 3371 - Evanston

Arizona

  • Site Reference ID/Investigator# 862 - Phoenix

Georgia

  • Site Reference ID/Investigator# 7113 - Roswell

Indiana

  • Site Reference ID/Investigator# 869 - Indianapolis

Louisiana

  • Site Reference ID/Investigator# 8054 - Baton Rouge

Trial Details

FieldValue
Enrollment Target 281 participants
Start Date 2006-12
Est. Completion 2009-06
Phase Phase 2
Abbott

181 total trials

What the finished NCT00421733 record still lists

NCT00421733 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 3,204-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00421733 names 20 study sites across 13 states, led by Florida, North Carolina, California.

Frequently Asked Questions

What is clinical trial NCT00421733 about?

NCT00421733 is a clinical study titled "The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors". 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/o...

What is the current status of trial NCT00421733?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 281 participants. The study started on 2006-12. Estimated completion is 2009-06.

What conditions does trial NCT00421733 study?

This clinical trial studies the following conditions: Chronic Kidney Disease, Diabetic Nephropathy.

What interventions are being tested in trial NCT00421733?

The interventions under investigation include: Placebo (DRUG), Zemplar (paricalcitol ) capsules (DRUG), Zemplar (paricalcitol) capsules (DRUG).

Who is sponsoring clinical trial NCT00421733?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00421733 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Kidney Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00421733's enrollment target sits among peer trials

281 31st of 101 higher than 71 of 101 other Chronic Kidney Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00421733, the US trial registry maintained by the National Library of Medicine. NCT00421733 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.