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Completed

NCT Number: NCT00902980

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

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

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New Westminster, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chart review

Other

Chart review of patients / graft outcome in renal transplant recipients

Primary outcomes

  1. 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

Secondary outcomes

  1. Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia

    Time frame: 6, 12 and 18 months

  2. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 15, 2009
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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