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

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ClinicalTrials.gov Identifier: NCT00902980
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment
Kidney Transplantation Other: 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 Type : Observational
Actual Enrollment : 264 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics
Study Start Date : April 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1. Community Based Clinics
Patient charts from community based nephrology clinics
Other: Chart Review
Chart review of patients / graft outcome in renal transplant recipients
2. Regional Clinics
Patient charts from regional transplant clinics
Other: Chart Review
Chart review of patients / graft outcome in renal transplant recipients



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Canadian subjects post renal transplant, currently being treated with immunosuppressive therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902980


Locations
Canada, British Columbia
New Westminster, British Columbia, Canada, V3L3W4
Vancouver, British Columbia, Canada, V5Z1M9
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C2Z3
St. John, New Brunswick, Canada, E2L4L2
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H1V7
Sydney, Nova Scotia, Canada, B1P1P3
Canada, Ontario
London, Ontario, Canada, N6A5A5
Mississauga, Ontario, Canada, L5M5W9
Sault Ste Marie, Ontario, Canada, P6A2C4
Sudbury, Ontario, Canada, P3E5J1
Thunder Bay, Ontario, Canada, P7E6E7
Toronto, Ontario, Canada, M5C2T2
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Canada, Inc.

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00902980     History of Changes
Other Study ID Numbers: FKC-010
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
Kidney transplantation
Tacrolimus
Immunosuppression

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs