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NCT01598987 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
A Phase 3 study of Liver Transplant and Renal Function, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT01598987: Completed Phase 3 study of Liver Transplant and Renal Function, sponsored by Novartis Pharmaceuticals.
NCT01598987 is a Phase 3 study of Liver Transplant and Renal Function that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 56 participants, below the 5,455-participant average among 19 other Liver Transplant trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01598987, a Phase 3 study of Liver Transplant and Renal Function, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
Primary Outcome
Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.
Conditions Studied
Interventions
- DRUG Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - København Ø
- Novartis Investigative Site - Bron
- Novartis Investigative Site - Bonn
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Hamburg
- Novartis Investigative Site - Regensburg
- Novartis Investigative Site - Tübingen
California
- Novartis Investigative Site - Los Angeles
Connecticut
- Novartis Investigative Site - New Haven
Illinois
- Novartis Investigative Site - Chicago
Missouri
- Novartis Investigative Site - St Louis
New York
- Novartis Investigative Site - New York
South Carolina
- Novartis Investigative Site - Charleston
Texas
- Novartis Investigative Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01598987 record still lists
NCT01598987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 5,455-participant average among 19 other Liver Transplant trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Liver Transplant appearing as the primary indexed condition, and to 1 intervention - of which Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation. is the first listed.
NCT01598987 names 20 study sites across 13 states, led by Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01598987 about?
NCT01598987 is a clinical study titled "Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.". This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
What is the current status of trial NCT01598987?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2012-10. Estimated completion is 2016-06.
What conditions does trial NCT01598987 study?
This clinical trial studies the following conditions: Liver Transplant, Renal Function.
What interventions are being tested in trial NCT01598987?
The interventions under investigation include: Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation. (DRUG).
Who is sponsoring clinical trial NCT01598987?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01598987 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01598987's enrollment target sits among peer trials
56 14th of 19 higher than 6 of 19 other Liver Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Transplant 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.
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