Clinical trial NCT00983645: A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
Official title: A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Transplant Rejection
Keywords: Kidney Transplantation
Immunosuppression
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.

Detailed description: This study aims to include Hispanics who have undergone a renal transplant to determine the specific outcome after renal transplantation, assuming that ethnic groups require different immunosuppressant regimens. Trough levels in transplant recipients determine the dosing requirements for Tacrolimus and Cyclosproine. It has been recently found, however, that testing cyclosporine levels in the blood 2 hours after taking cyclosporine is more effective in dosing cyclosprine for renal transplant patients than trough levels. The specific study aims include comparing the cyclosporine monitoring in patients with trough and C2 levels, and adjusting immunosuppression based on C2 levels.

Eligibility criteria: Inclusion Criteria:

* Cadaveric or Living Donors
* 18 years old or greater
* Primary renal transplants
* Hispanic ethnicity

Exclusion Criteria:

* Prior renal transplant
* Multi-organ transplant
* Recipient with history of Diabetes Mellitus
* PRA \> 20%
* Cold Ischemia Time \> 24 hours

Primary outcomes:
measure: Rejection
timeFrame: 6 months post-transplant
Secondary outcomes:
measure: Renal Function
timeFrame: 6 months post-transplant
measure: Post-transplant Diabetes Mellitus
timeFrame: 6 months post-transplant
measure: Lipid Levels
timeFrame: 6 months post-transplant
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Pedro Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Jindal RM, Hjelmesaeth J. Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. No abstract available.
citation: 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.
citation: 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.