Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics

Kidney Transplantation Clinical Trial

Official title:

Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902980
• Other study ID #: FKC-010
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: September 17, 2014
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Other:
• Chart Review
Chart review of patients / graft outcome in renal transplant recipients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)		6, 12 and 18 months	No
Secondary	Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia		6, 12 and 18 months	Yes
Secondary	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		6, 12 and 18 months	Yes

External Links

•   Link to Results on JAPIC - enter 140607 in the JapicCTI-RNo. field