A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
NCT ID: NCT00983645
Last Updated: 2016-06-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
15 participants
INTERVENTIONAL
2004-10-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoral
Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral
Cyclosporine (Neoral) starting dose 3mg/kg PO BID
Prograf
Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf
Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
Interventions
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Prograf
Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
Neoral
Cyclosporine (Neoral) starting dose 3mg/kg PO BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years old or greater
* Primary renal transplants
* Hispanic ethnicity
Exclusion Criteria
* Multi-organ transplant
* Recipient with history of Diabetes Mellitus
* PRA \> 20%
* Cold Ischemia Time \> 24 hours
18 Years
70 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Pedro Baron, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Countries
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References
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Neylan JF. Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group. Transplantation. 1998 Feb 27;65(4):515-23. doi: 10.1097/00007890-199802270-00011.
First MR, Gerber DA, Hariharan S, Kaufman DB, Shapiro R. Posttransplant diabetes mellitus in kidney allograft recipients: incidence, risk factors, and management. Transplantation. 2002 Feb 15;73(3):379-86. doi: 10.1097/00007890-200202150-00011.
Jindal RM, Hjelmesaeth J. Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. No abstract available.
Knoll GA, Bell RC. Tacrolimus versus cyclosporin for immunosuppression in renal transplantation: meta-analysis of randomised trials. BMJ. 1999 Apr 24;318(7191):1104-7. doi: 10.1136/bmj.318.7191.1104.
Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.
Other Identifiers
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53271
Identifier Type: -
Identifier Source: org_study_id
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