Status:
COMPLETED
Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Canadian surgical research fund
Astellas Pharma Canada, Inc.
Conditions:
Obesity, Morbid
Transplant; Failure, Kidney
Eligibility:
All Genders
18+ years
Brief Summary
A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.
Detailed Description
The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, wei...
Eligibility Criteria
Inclusion
- adult (\>18 years)
- stage IV and V chronic renal disease (glomerular filtration rate \< 30 ml/min,
- body mass index (BMI) of greater than 40 kg/m2 or \> 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes
Exclusion
- medically unfit for surgical intervention
- previous gastric or intestinal surgery
- active gastric disease
- pregnancy or lactation
- known intolerance to tacrolimus or mycophenolic acid
- awaiting potential multi-organ transplantation
- active infection
Key Trial Info
Start Date :
July 18 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01913392
Start Date
July 18 2013
End Date
May 1 2018
Last Update
December 2 2019
Active Locations (1)
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1
MaisonneuveRH
Montreal, Quebec, Canada, H1T 2M4