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

NCT ID: NCT00902980

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1. Community Based Clinics

Patient charts from community based nephrology clinics

Chart Review

Intervention Type OTHER

Chart review of patients / graft outcome in renal transplant recipients

2. Regional Clinics

Patient charts from regional transplant clinics

Chart Review

Intervention Type OTHER

Chart review of patients / graft outcome in renal transplant recipients

Interventions

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Chart Review

Chart review of patients / graft outcome in renal transplant recipients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Canada, Inc.

Locations

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New Westminster, British Columbia, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Moncton, New Brunswick, Canada

Site Status

Saint John, New Brunswick, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Sydney, Nova Scotia, Canada

Site Status

Greater Sudbury, Ontario, Canada

Site Status

London, Ontario, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

Sault Ste. Marie, Ontario, Canada

Site Status

Thunder Bay, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Keough-Ryan TM, Prasad GV, Hewlett T, Shapiro RJ; Canadian Community Nephrology Study Group. Similar outcomes for Canadian renal transplant recipients followed up in transplant centers and satellite clinics. Transplantation. 2010 Sep 27;90(6):591-6. doi: 10.1097/tp.0b013e3181e9febd.

Reference Type BACKGROUND
PMID: 20865815 (View on PubMed)

Prasad GV, Nash MM, Keough-Ryan T, Shapiro RJ. A quality of life comparison in cyclosporine- and tacrolimus-treated renal transplant recipients across Canada. J Nephrol. 2010 May-Jun;23(3):274-81.

Reference Type BACKGROUND
PMID: 20383867 (View on PubMed)

Other Identifiers

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FKC-010

Identifier Type: -

Identifier Source: org_study_id

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