Renal TransplantationPhase 4NCT00637143
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
A Phase 4 study testing Tacrolimus and Cyclosporine in people with Renal Transplantation and Chronic Renal Allograft Failure, run by Astellas Pharma Inc at 13 sites in Canada.
Trial summary
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Renal Transplantation, Chronic Renal Allograft Failure
- What is being tested?
- Tacrolimus and Cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 13 sitesCanada
- Study dates
- Apr 1999to Feb 2006
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
- Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
- Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
- Serum creatinine: Male: >=2.0mg/dL (176.8 umol/L); Female: >= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
- Serum creatinine > 30% increased over post-discharge nadir
- Patient has had a renal biopsy > 3 months after transplant and within 6 months prior to enrollment
- Patient or legal guardian has signed and dated an IRB approved informed consent document
- Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)
Who cannot join
- Patient is dialysis dependent and has recurrence of primary or de novo renal disease
- Patient has an estimated creatinine clearance <25mL/min
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
- Baseline biopsy shows acute rejection Grade >=IIB using Banff 95 criteria or >= Grade IIA using Banff 97 criteria
- Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
- Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
- Patient is a known carrier of any of the HIV viruses
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Halifax, Nova Scotia, B3H 1V8
Study site
Hamilton, Ontario, L8N 4A6
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H3A 1A1
Study site
Saskatoon, Saskatchewan, S7M 0Z9
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
Study site
Toronto, Ontario, M5C 2T2
Study site
Toronto, Ontario, M5G 2N2
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.
Read the detailed description
The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.
- Being tested
- Tacrolimus, Cyclosporine
- Keywords
- Renal transplant, Cyclosporine, Tacrolimus, Intervention, Interstitial Fibrosis Tubular Atrophy, Chronic Renal Allograft Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506, Prograf
Oral
CyclosporineDrug
Also called Neoral
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Receives: Drug: Tacrolimus |
| 2 | Active comparator | Oral Receives: Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival
Measured: 5 years
Secondary outcomes (1)
Patient Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startApr 1999
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 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
- Central Contact, Study chair, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637143
- Sponsor's protocol ID
- FKC-003
- Status last verified
- Feb 2017
- First submitted
- 10 Mar 2008
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B. Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.
PubMed 18852662
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
- ClinicalTrials.gov ID
- NCT00637143
- Acronym / sponsor ID
- FKC-003
- Keywords
- Renal transplant, Cyclosporine, Tacrolimus, Intervention, Interstitial Fibrosis Tubular Atrophy, Chronic Renal Allograft Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Apr 1999
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Mar 2008 (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.
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.
Detailed description
The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TacrolimusOral |
| 2 | Active comparator | Drug: CyclosporineOral |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
- Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
- Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
- Patient has had a renal biopsy > 3 months after transplant and within 6 months prior to enrollment
- Patient or legal guardian has signed and dated an IRB approved informed consent document
Key exclusion criteria (7 listed)
- Patient is dialysis dependent and has recurrence of primary or de novo renal disease
- Patient has an estimated creatinine clearance <25mL/min
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
- Baseline biopsy shows acute rejection Grade >=IIB using Banff 95 criteria or >= Grade IIA using Banff 97 criteria
- Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
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 |
|---|---|---|
| TacrolimusAlso: FK506, PrografOral | Drug | 1 |
| CyclosporineAlso: NeoralOral | Drug | 2 |
Primary outcome
Graft Survival
Time frame: 5 years
1 secondary outcome
Patient Survival
Time frame: 5 years
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 16 Feb 2017.
- Background: PubMed 18852662Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B. Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Central Contact study chair
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?
A Phase 4 study testing Tacrolimus and Cyclosporine in people with Renal Transplantation and Chronic Renal Allograft Failure, 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 7 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 16 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Graft Survival (time frame: 5 years). 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 NCT00637143, which also lists 1 linked publication.
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 16 Feb 2017.