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

Completed

• Conditions: Kidney Transplantation
• Interventions: Other: Chart Review

• Registration Number: NCT00902980
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. Community Based Clinics	Chart Review	Patient charts from community based nephrology clinics
2. Regional Clinics	Chart Review	Patient charts from regional transplant clinics

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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