Clinical trial NCT00902980: Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
Official title: Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Kidney transplantation
Tacrolimus
Immunosuppression
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2009-05-15
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Canadian subjects post renal transplant, currently being treated with immunosuppressive therapy

Brief summary: This is a multicentre, observational, non-interventional, retrospective analysis by chart review.

Detailed description: This study will compare differences in patient and graft related outcomes in renal transplant recipients followed in regional transplant centers versus satellite clinics.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 months post transplant
* Patient had the current transplant during the period 1 July 1997 to no less than 18 months prior to chart review
* Patient is currently on tacrolimus/MMF or AZA - or cyclosporine/MMF or AZA based immunosuppressive therapy
* Patient is not a recipient of dual kidney or multi -organ transplant
* Patient has a functioning graft (i.e. patient does not require dialysis)
* Patient is recipient of a renal transplant including living or cadaveric, related or non-related, or pediatric en bloc kidneys, but excluding kidney-pancreas transplant recipients
* Patient received the current transplant at one of six identified regional transplant centers
* Patient is currently followed in a regional or satellite community based nephrology clinic

Primary outcomes:
measure: Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)
timeFrame: 6, 12 and 18 months
Secondary outcomes:
measure: Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia
timeFrame: 6, 12 and 18 months
measure: Comparison of patients on cyclosporine-vs. tacrolimus-based immunoprophylaxis as well as community-based vs. regional transplant nephrology clinics in both incidence of toxicities and related clinical interventions
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: St. John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Sydney
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Sault Ste Marie
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Keough-Ryan TM, Prasad GV, Hewlett T, Shapiro RJ; Canadian Community Nephrology Study Group. Similar outcomes for Canadian renal transplant recipients followed up in transplant centers and satellite clinics. Transplantation. 2010 Sep 27;90(6):591-6. doi: 10.1097/tp.0b013e3181e9febd.
citation: Prasad GV, Nash MM, Keough-Ryan T, Shapiro RJ. A quality of life comparison in cyclosporine- and tacrolimus-treated renal transplant recipients across Canada. J Nephrol. 2010 May-Jun;23(3):274-81.