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NCT00774852 · ClinicalTrials.gov registry record · Phase 2

Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
137
Enrollment target

NCT00774852: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00774852 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00774852, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
137 participants
Enrollment target

Study Summary

This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.

Primary Outcome

Complete response definition: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent v

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • DRUG abatacept
  • DRUG azathioprine
  • DRUG abatacept placebo

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2008-11
Est. Completion 2014-06
Phase Phase 2

What the finished NCT00774852 record still lists

NCT00774852 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.

NCT00774852 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00774852 about?

NCT00774852 is a clinical study titled "Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis". This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophospha...

What is the current status of trial NCT00774852?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2008-11. Estimated completion is 2014-06.

What interventions are being tested in trial NCT00774852?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), abatacept (DRUG), azathioprine (DRUG), abatacept placebo (DRUG).

Who is sponsoring clinical trial NCT00774852?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00774852's enrollment target sits among peer trials

137 527th of 2000 higher than 1,474 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00774852, the US trial registry maintained by the National Library of Medicine. NCT00774852 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.