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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00902980

Enrollment

264

Registered

2009-05-15

Start date

2005-04-30

Completion date

2006-12-31

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplantation, Tacrolimus, Immunosuppression

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.

Interventions

OTHERChart Review

Chart review of patients / graft outcome in renal transplant recipients

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026