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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00902980
First received: May 13, 2009
Last updated: November 18, 2010
Last verified: May 2009
  Purpose

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


Condition Intervention
Kidney Transplantation
Other: Chart Review

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 264
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902980

Locations
Canada, British Columbia
New Westminster, British Columbia, Canada, V3L3W4
Vancouver, British Columbia, Canada, V5Z1M9
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C2Z3
St. John, New Brunswick, Canada, E2L4L2
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H1V7
Sydney, Nova Scotia, Canada, B1P1P3
Canada, 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
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
  More Information

No publications provided

Responsible Party: Sr Mgr Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT00902980     History of Changes
Other Study ID Numbers: FKC-010
Study First Received: May 13, 2009
Last Updated: November 18, 2010
Health Authority: Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Kidney transplantation
Tacrolimus
Immunosuppression

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014