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PRIDE - Prograf Investigation of Diet and Exercise. A Pilot Trial of the Effect of Dietary and Exercise Intervention in Patients Who Have Received a Renal Transplant on Tacrolimus (Prograf®)
This study is currently recruiting participants.
Verified by Janssen-Cilag Pty Ltd, April 2009
First Received: June 25, 2007   Last Updated: April 30, 2009   History of Changes
Sponsored by: Janssen-Cilag Pty Ltd
Information provided by: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00492661
  Purpose

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 kidney transplant recipients on tacrolimus.


Condition Intervention Phase
Renal Transplantation
Transplantation, Renal
Grafting, Kidney
Transplantation, Kidney
Drug: FK506 Prograf (tacrolimus) with diet and exercise intervention.
Phase IV

MedlinePlus related topics: Diets Exercise and Physical Fitness Kidney Transplantation
Drug Information available for: Insulin Tacrolimus anhydrous Tacrolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Trial of the Effect of Dietary and Exercise Intervention on Insulin Resistance and Metabolic Parameters in de Novo Renal Transplant Recipients on Prograf® (Tacrolimus)

Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • Proportion of patients with insulin resistance, as defined by a homeostasis model assessment (HOMA-IR) of >1 at 6 months.

Secondary Outcome Measures:
  • Proportion of patients with composite endpoint of impaired fasting glycaemia (IFG) /impaired glucose tolerance (IGT) /diabetes mellitus (DM) at 6 months.

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

This study will investigate the effect of a supervised diet and exercise program on the risk of developing diabetes and other related conditions after kidney transplantation. The exercise and diet intervention will include a 6-month program of weight lifting exercises (progressive resistance training) which will be completed three times each week and individualised dietary advice from a qualified dietician. Diabetes is very common following transplantation, developing in up to one-third of kidney transplant recipients. The development of diabetes requires treatment and places those affected at an increased risk of other complications including reduced transplant survival. This is a prospective (subjects are identified and then followed forward in time), single-arm, multicentre, interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. The subject population includes kidney transplant recipients who have been assigned a tacrolimus-based immunosuppression regimen. The study will include the following evaluations of safety and tolerability; adverse events will be reported by the patient for the duration of the study, a physical examination will be completed by the investigator at each study visit, laboratory investigations and an ECG will be performed at each study visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Received a living-donor or dead-donor, blood type compatible kidney transplant
  • Patient has sufficiently recovered from surgery to tolerate an intensive exercise evaluation
  • Patient is 18 years or older at the time of transplantation
  • Patient has been initiated on tacrolimus (Prograf)

Exclusion Criteria:

  • No significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina and/or other unstable disease, severe cognitive impairment)
  • No significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence or infection)
  • No 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)
  • No mobility problems
  • Patient does not require ongoing systemic immunosuppressive therapy for an indication other than renal transplant e.g. rheumatoid arthritis, and this dose is higher than that required for their kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492661

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
Australia
Recruiting
Woodville, Australia, 5011
Recruiting
Perth, Australia, 6001
Recruiting
Camperdown N/A, Australia, 2050
Recruiting
Clayton, Australia, 3168
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag Pty Ltd ( Executive Director, Medical & Scientific Affairs )
Study ID Numbers: CR013702
Study First Received: June 25, 2007
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00492661     History of Changes
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
weight lifting, resistance training.
insulin resistance syndrome X
tacrolimus
Prograf
Renal transplantation

Study placed in the following topic categories:
Body Weight
Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Immunologic Factors
Tacrolimus
Insulin Resistance
Glucose Metabolism Disorders
Immunosuppressive Agents
Metabolic Disorder
Insulin
Abdominal Obesity Metabolic Syndrome

Additional relevant MeSH terms:
Hyperinsulinism
Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Insulin Resistance
Glucose Metabolism Disorders
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009