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

• Sponsor: Loma Linda University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00983645
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 101
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Rejection	Drug: Prograf; Drug: Neoral	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neoral Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants	Drug: Neoral; Cyclosporine (Neoral) starting dose 3mg/kg PO BID; Other Names: Cyclosporine
Active Comparator: Prograf Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.	Drug: Prograf; Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID; Other Names: Tacrolimus

Outcome Measures

Primary Outcome Measures

1. Rejection [6 months post-transplant]

Secondary Outcome Measures

1. Renal Function [6 months post-transplant]

2. Post-transplant Diabetes Mellitus [6 months post-transplant]

3. Lipid Levels [6 months post-transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Pedro Baron, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT00983645
• Other Study ID Numbers: 53271
• First Posted: Sep 24, 2009
• Last Update Posted: Jun 3, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Loma Linda University: Kidney Transplantation; Immunosuppression
• Additional relevant MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins

Study Results

Participant Flow

Arm/Group Title	Neoral	Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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
Period Title: Overall Study
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Neoral	Prograf	Total
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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	Total of all reporting groups
Overall Participants	8	7	15
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	29.875	42.14	35.6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	7 100%	15 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 25%	3 42.9%	5 33.3%
Male	6 75%	4 57.1%	10 66.7%
Region of Enrollment (participants) [Number]
United States	8 100%	7 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Rejection
Time Frame	6 months post-transplant

Outcome Measure Data

Analysis Population Description

Data cannot be located for analysis.

Arm/Group Title	Neoral	Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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
Measure Participants	0	0

2. Secondary Outcome

Title	Renal Function
Time Frame	6 months post-transplant

Outcome Measure Data

Analysis Population Description

Data cannot be located for analysis.

Arm/Group Title	Neoral	Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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
Measure Participants	0	0

3. Secondary Outcome

Title	Post-transplant Diabetes Mellitus
Time Frame	6 months post-transplant

Outcome Measure Data

Analysis Population Description

Data cannot be located for analysis.

Arm/Group Title	Neoral	Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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
Measure Participants	0	0

4. Secondary Outcome

Title	Lipid Levels
Time Frame	6 months post-transplant

Outcome Measure Data

Analysis Population Description

Data cannot be located for analysis.

Arm/Group Title	Neoral	Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID	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
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Standard practice
Arm/Group Title	Neoral		Prograf
Arm/Group Description	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID		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
All Cause Mortality
	Neoral		Prograf
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Neoral		Prograf
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Neoral		Prograf
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)

Limitations/Caveats

A limitation to this study is early termination leading to a small number of subjects.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.