A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate whether a combined dietary and exercise intervention, added to standard care, reduces the expected frequency of insulin resistance in renal (kidney) transplant recipients on tacrolimus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Pty Ltd
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Participants who has sufficiently recovered from surgery to tolerate an intensive exercise evaluation

• Participants who have received a living-donor or cadaveric (from dead donor) renal transplant

• Participants who has been initiated tacrolimus as first-line immunosuppressive agent

• Participants who has given informed consent forms

Exclusion Criteria:

• Participants with significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina [chest pain due to decreased oxygen being supplied to the heart] and/or other unstable disease, severe cognitive [mental functioning] impairment)

• Participants with significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence [pathologic process consisting of a partial or complete disruption of the layers of a surgical wound] or infection)

• Participants with contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, New York Heart Association (NYHA) class-IV congestive heart failure)

• Participants with non-ambulatory (mobility) status

• Participants who require ongoing systemic immunosuppressive therapy for an indication other than renal transplant and this therapy is higher than that required for their kidney disease