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)
Information source: Janssen-Cilag Pty Ltd
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Grafting, Kidney; Renal Transplantation; Transplantation, Kidney; Transplantation, Renal
Intervention: FK506 Prograf (tacrolimus) with diet and exercise intervention. (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Janssen-Cilag Pty Ltd Official(s) and/or principal investigator(s):
Janssen-Cilag Pty Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pty Ltd
Overall 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:, Email: info1@veritasmedicine.com
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 kidney transplant recipients on tacrolimus.
Clinical Details
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)
Study design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients with insulin resistance, as defined by a homeostasis model assessment (HOMA-IR) of >1 at 6 months.
Secondary outcome: Proportion of patients with composite endpoint of impaired fasting glycaemia (IFG) /impaired glucose tolerance (IGT) /diabetes mellitus (DM) at 6 months.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
Woodville, Australia; Recruiting
Perth, Australia; Recruiting
Camperdown N/A, Australia; Recruiting
Clayton, Australia; Recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: July 2007
Ending date: June 2010
Last updated: October 15, 2009
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