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

September 17, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L3W4
      • Vancouver, British Columbia, Canada, V5Z1M9
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C2Z3
      • St. John, New Brunswick, Canada, E2L4L2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
      • Sydney, Nova Scotia, Canada, B1P1P3
    • Ontario
      • London, Ontario, Canada, N6A5A5
      • Mississauga, Ontario, Canada, L5M5W9
      • Sault Ste Marie, Ontario, Canada, P6A2C4
      • Sudbury, Ontario, Canada, P3E5J1
      • Thunder Bay, Ontario, Canada, P7E6E7
      • Toronto, Ontario, Canada, M5G2N2
      • Toronto, Ontario, Canada, M5C2T2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Canadian subjects post renal transplant, currently being treated with immunosuppressive therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. Community Based Clinics
Patient charts from community based nephrology clinics
Other: Chart Review
Chart review of patients / graft outcome in renal transplant recipients
2. Regional Clinics
Patient charts from regional transplant clinics
Other: Chart Review
Chart review of patients / graft outcome in renal transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)
Time Frame: 6, 12 and 18 months
6, 12 and 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia
Time Frame: 6, 12 and 18 months
6, 12 and 18 months
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
Time Frame: 6, 12 and 18 months
6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Canada, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FKC-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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