- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239785
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
August 18, 2017 updated by: Novartis Pharmaceuticals
A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
Study Overview
Study Type
Interventional
Enrollment
684
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria
- Male and female patients of any race between 18 to 65 years old (inclusive)
- Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
- Patients who gave written informed consent to participate in the study Exclusion Criteria
- Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
- Graft cold ischemia time greater than 40 hours.
- Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
|
Permanent resumption of dialysis within 12 months post transplant
|
Surgical removal of graft within 12 months post transplant
|
Death within 12 months post transplant
|
Withdrawal of consent, death, or lost to follow up within 12 months post transplant
|
Secondary Outcome Measures
Outcome Measure |
---|
Serum creatinine
|
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
|
Cystatin C at months 3, 6, and 12
|
Proteinuria at day 28, months 6 and 12
|
Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
October 13, 2005
First Submitted That Met QC Criteria
October 13, 2005
First Posted (Estimate)
October 17, 2005
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 18, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CFTY720A0124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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