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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00492661 on ClinicalTrials.gov