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NCT01436305 · ClinicalTrials.gov registry record · Phase 2
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01436305: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01436305 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01436305, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.
Primary Outcome
GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.
Interventions
- DRUG Alemtuzumab
- BIOLOGICAL Basiliximab
- DRUG MMF
- DRUG tacrolimus
- DRUG Short-term Tac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01436305 stopped before completion
NCT01436305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Alemtuzumab is the first listed.
NCT01436305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01436305 about?
NCT01436305 is a clinical study titled "Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation". The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment ...
What is the current status of trial NCT01436305?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2011-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01436305?
The interventions under investigation include: Alemtuzumab (DRUG), Basiliximab (BIOLOGICAL), MMF (DRUG), tacrolimus (DRUG), Short-term Tac (DRUG).
Who is sponsoring clinical trial NCT01436305?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436305's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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