Kidney TransplantationNCT00902980
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
An observational study of Kidney Transplantation, run by Astellas Pharma Inc at 13 sites in Canada.
Trial summary
This is a multicentre, observational, non-interventional, retrospective analysis by chart review. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Chart Review
- How many people
- 264 participants
- Where
- 13 sitesCanada
- Study dates
- Apr 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadian subjects post renal transplant, currently being treated with immunosuppressive therapy
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Study site
Greater Sudbury, Ontario, P3E5J1
Study site
Halifax, Nova Scotia, B3H1V7
Study site
London, Ontario, N6A5A5
Study site
Mississauga, Ontario, L5M5W9
Study site
Moncton, New Brunswick, E1C2Z3
Study site
New Westminster, British Columbia, V3L3W4
Study site
Saint John, New Brunswick, E2L4L2
Study site
Sault Ste. Marie, Ontario, P6A2C4
Study site
Sydney, Nova Scotia, B1P1P3
Study site
Thunder Bay, Ontario, P7E6E7
Study site
Toronto, Ontario, M5C2T2
Study site
Toronto, Ontario, M5G2N2
Study site
Vancouver, British Columbia, V5Z1M9
About this study
Official title: Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- Chart Review
- Keywords
- Kidney transplantation, Tacrolimus, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart ReviewOther
Chart review of patients / graft outcome in renal transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| 1. Community Based Clinics | Patient charts from community based nephrology clinics Receives: Other: Chart Review | |
| 2. Regional Clinics | Patient charts from regional transplant clinics Receives: Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR)
Measured: 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
Measured: 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
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902980
- Sponsor's protocol ID
- FKC-010
- Status last verified
- Sep 2014
- First submitted
- 13 May 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20865815Prasad 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.
PubMed 20383867
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics
- ClinicalTrials.gov ID
- NCT00902980
- Acronym / sponsor ID
- FKC-010
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, Tacrolimus, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Apr 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Community Based Clinics | – | Other: Chart ReviewPatient charts from community based nephrology clinics |
| 2. Regional Clinics | – | Other: Chart ReviewPatient charts from regional transplant clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian subjects post renal transplant, currently being treated with immunosuppressive therapy
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chart ReviewChart review of patients / graft outcome in renal transplant recipients | Other | 1. Community Based Clinics, 2. Regional Clinics |
Primary outcome
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
2 secondary outcomes
Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia
Time frame: 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
Time frame: 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Background: PubMed 20865815Keough-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.
- Background: PubMed 20383867Prasad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Canada, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Astellas Pharma Inc at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.