A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Renal Transplant Rejection Clinical Trial

Official title:

A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00983645
• Other study ID #: 53271
• Status: Terminated
• Phase: Phase 4
• First received: September 23, 2009
• Last updated: September 17, 2015
• Start date: October 2004
• Est. completion date: March 2013

Study information

• Verified date: September 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant Rejection

Intervention

Drug:
• Prograf
Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
• Neoral
Cyclosporine (Neoral) starting dose 3mg/kg PO BID

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Jindal RM, Hjelmesaeth J. Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejection		6 months post-transplant	No
Secondary	Renal Function		6 months post-transplant	No
Secondary	Post-transplant Diabetes Mellitus		6 months post-transplant	No
Secondary	Lipid Levels		6 months post-transplant	No