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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00492661




Registration number
NCT00492661
Ethics application status
Date submitted
25/06/2007
Date registered
27/06/2007
Date last updated
27/05/2013

Titles & IDs
Public title
A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
Scientific 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)
Secondary ID [1] 0 0
OTH/506TRA4004
Secondary ID [2] 0 0
CR013702
Universal Trial Number (UTN)
Trial acronym
PRIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplantion 0 0
Kidney Transplantion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus With Diet and Exercise Intervention

Experimental: Tacrolimus With Diet and Exercise Intervention - Participants on tacrolimus for immunosuppression (drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity) will be provided with intensive dietary advice and supervised progressive resistance training (PRT) for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Insulin Resistance
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Impaired Fasting Glycaemia (IFG)
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With Impaired Glucose Tolerance (IGT)
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Diabetes Mellitus (DM)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Beta Cell Function
Timepoint [4] 0 0
Baseline, Week 4, Week 12, and Week 24
Secondary outcome [5] 0 0
Number of Participants With Acute Rejection, Graft Loss and Death
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Body Mass Index (BMI)
Timepoint [6] 0 0
Baseline, Week 4, Week 12 and Week 24
Secondary outcome [7] 0 0
Bone Mineral Density
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Waist to Hip Ratio (WHR)
Timepoint [8] 0 0
Baseline, Week 4, Week 12 and Week 24
Secondary outcome [9] 0 0
Body Composition: Percent Body Fat
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Body Composition: Lean Mass, Bone Mass and Adjusted Weight
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Body Composition: T Score (Full Body) and Z Score (Full Body)
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Blood Pressure: Systolic and Diastolic Pressure
Timepoint [12] 0 0
Baseline, Week 4, Week 12 and Week 24
Secondary outcome [13] 0 0
Lipid Profile
Timepoint [13] 0 0
Baseline, Week 4, Week 12, and Week 24
Secondary outcome [14] 0 0
Hemoglobin A, Glycosylated (HbA1c)
Timepoint [14] 0 0
Baseline, Week 4, Week 12 and Week 24
Secondary outcome [15] 0 0
Estimated Glomerular Filtration Rate (eGFR)
Timepoint [15] 0 0
Baseline, Week 4, Week 12 and Week 24
Secondary outcome [16] 0 0
36-Item Short-Form (SF-36) Score - Health Survey
Timepoint [16] 0 0
Baseline, Week 12 and Week 24
Secondary outcome [17] 0 0
Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS)
Timepoint [17] 0 0
Week 4, Week 12 and Week 24
Secondary outcome [18] 0 0
Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program
Timepoint [18] 0 0
Week 4, Week 12 and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown N/A
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Camperdown N/A
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Woodville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00492661