NCT00902980

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

May 13, 2009

Last Update Submit

September 17, 2014

Conditions

Kidney Transplantation

Keywords

Kidney transplantationTacrolimusImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

1. Community Based Clinics

Patient charts from community based nephrology clinics

Other: Chart Review

2. Regional Clinics

Patient charts from regional transplant clinics

Other: Chart Review

Interventions

Chart ReviewOTHER

Chart review of patients / graft outcome in renal transplant recipients

1. Community Based Clinics2. Regional Clinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

New Westminster, British Columbia, V3L3W4, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z1M9, Canada

Location

Unknown Facility

Moncton, New Brunswick, E1C2Z3, Canada

Location

Unknown Facility

Saint John, New Brunswick, E2L4L2, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H1V7, Canada

Location

Unknown Facility

Sydney, Nova Scotia, B1P1P3, Canada

Location

Unknown Facility

Greater Sudbury, Ontario, P3E5J1, Canada

Location

Unknown Facility

London, Ontario, N6A5A5, Canada

Location

Unknown Facility

Mississauga, Ontario, L5M5W9, Canada

Location

Unknown Facility

Sault Ste. Marie, Ontario, P6A2C4, Canada

Location

Unknown Facility

Thunder Bay, Ontario, P7E6E7, Canada

Location

Unknown Facility

Toronto, Ontario, M5C2T2, Canada

Location

Unknown Facility

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 20865815BACKGROUND

  • 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.

    PMID: 20383867BACKGROUND

Study Officials

  • Use Central Contact

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

April 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

CA(13)