Expired Study
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Miami, Florida 33136


Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.


Inclusion Criteria: - Age >14 years - Weight > 40 kg - Primary renal allograft: cadaveric or mismatched living donor - Negative standard cross match for T-cells - Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.) - Signed and dated informed consent (Parent or legal guardian must provide written consent for patients <18 years of age) Exclusion Criteria: - Evidence of systemic infection - History of malignancy within 10 years (with the exception of localized skin cancer) - Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase - Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole - Known hypersensitivity to sirolimus and its derivatives - Patients with a screening/baseline (or within 96 hours of transplant) - total white blood cell count < 4000/mm3; - platelet count < 100,000/mm3; - fasting triglycerides > 400 mg/dl (> 4.6 mmol/L); - fasting total cholesterol > 300 mg/dl (> 7.8 mmol/L); - fasting HDL-cholesterol < 30 mg/dl; - fasting LDL-cholesterol > 200mg/dl

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation

Official Title:

Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

Overall Status:


Study Phase:

Phase 4



Minimum Age:

16 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Miami

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:May 2000
Completion Date:December 2002
Completion Type:Actual
Primary Completion Date:December 2001
Primary Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 23, 2008
First Received Date:May 19, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months
Time Frame:1, 3, and 5 years
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Incidence and severity of acute rejection episodes
Time Frame:1 year
Safety Issues:True

Study Interventions

Intervention Type:Drug
Arm Name:A
Intervention Type:Drug
Arm Name:B
Intervention Type:Drug
Arm Name:C

Study Arms

Study Arm Type:Experimental
Arm Name:A
Study Arm Type:Experimental
Arm Name:B
Study Arm Type:Experimental
Arm Name:C

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Miami
Agency Class:Other
Agency Type:Collaborator
Agency Name:Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Ciancio G, Burke GW, Gaynor JJ, Ruiz P, Roth D, Kupin W, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimums/mycophenolate versus cyclosporine/sirolimus in renal transplantation: three-year analysis. Transplantation. 2006 Mar 27;81(6):845-52.
Reference Type:Results Reference
Citation:Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at 1 year. Transplantation. 2004 Jan 27;77(2):252-8.
Reference Type:Results Reference
Citation:Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J. A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (NEORAL) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation. 2004 Jan 27;77(2):244-51. Erratum in: Transplantation. 2004 Apr 15;7797):1131.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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