- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555373
Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression (CNI-W)
Novel Pilot Trial of Sirolimus, Mycophenolate Mofetil, and Corticosteroids Versus a Historic Control Population Receiving Calcineurin Inhibitors Based Immunosuppression
Damage and scarring of a transplanted kidney has become the most common cause of loss of the transplanted kidney. This kidney damage is a complex process caused by many factors including injury during obtaining and transplanting the kidney, injury from the immune system, injury from infections, and injury from drugs used to stop rejection. This injury leads to scars that decrease the kidney's ability to function properly, and over time the kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when used over time it has been shown to cause chronic damage and scarring in the transplanted kidney.
The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin® (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney. A total of 50 children will enroll in this study at university centers around the country. This study will last about 3 years.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- Pediatric Nephrology of Alabama
-
-
California
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Los Angeles, California, United States, 90095
- UCLA
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Stanford, California, United States, 94305
- Stanford University
-
-
Georgia
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Atlanta, Georgia, United States
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria at Transplant:
- Age < 19 years (up to the day of the 19th birthday)
- Panel Reactive Antibody Level (PRA) <20% (Flow cytometry method)
- Recipient of first living donor or deceased donor renal transplantation
- Signed and dated informed consent (per local IRB standards)
Exclusion Criteria at Transplant:
- Recipients of multi-organ transplants (e.g. kidney/pancreas transplant, etc.)
- Peak PRA > 20% at any time
- Recipient of en-bloc kidneys
- Recipient of an organ from an HLA identical donor or a non-heart beating donor
- Pregnant or lactating
- Positive for HIV or an immunodeficiency virus
- History of malignancy
- Use of investigational agents within 4 weeks prior to transplantation
- Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued before administration of SRL)
- Known hypersensitivity to sirolimus
- Known hypersensitivity to Prograf, Cellcept, prednisone, Cremophor, HCO-60, or murine products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Sirolimus
Single arm
|
At 6 months post-transplantation, all patients will be administered Sirolimus at a dose of 1.65-2.79 mg/m2/day as a tablet or liquid (administered q 12 hours).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
This study has a primary endpoint of allograft function as determined by Schwartz GFR at 18 months after conversion to CNI free protocol (2 years post transplantation).
Time Frame: 18 mos after conversion to CNI free protocol
|
18 mos after conversion to CNI free protocol
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes will include biopsy proven acute rejection episodes, progression of quantitative interstitial fibrosis as determined by Sirius Red staining and digital image analysis, Allograft survival and patient survival
Time Frame: measured at 12 and 24 months post transplant
|
measured at 12 and 24 months post transplant
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Benfield, M.D., Pediatric Nephrology of Alabama
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIRB Pr. No.: 20101428
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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