A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
NCT00492661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2013-05-27
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.
Conditions
- Renal Transplantion
- Kidney Transplantion
Interventions
- DRUG
-
Tacrolimus With Diet and Exercise Intervention
Participants on tacrolimus for immunosuppression will be provided with intensive dietary advice and supervised for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
Sponsors & Collaborators
-
Janssen-Cilag Pty Ltd
lead INDUSTRY
Principal Investigators
-
Janssen-Cilag Pty Ltd Clinical Trial · Janssen-Cilag Pty Ltd
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- Australia
Study Locations
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