Kidney TransplantationPhase 4NCT00133172
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
A Phase 4 study testing Tacrolimus, mycophenolate mofetil and Prednisone in people with Kidney Transplantation, run by Astellas Pharma Inc at 14 sites in Canada.
Trial summary
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation. 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?
- Tacrolimus, mycophenolate mofetil and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 14 sitesCanada
- Study dates
- Jul 2005to Mar 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
- Subject is 18 years of age or over at the time of transplant.
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Who cannot join
- Recipients of a kidney from a donor 60 years of age or older
- Recipients of donation after cardiac death (DCD) donors
- Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
- Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
- Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
- Subjects with hepatitis B \& C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
Show all 11Show fewer
- Subjects receiving an allograft with cold ischemia time 24 hours or greater
- Subjects who have received an investigational drug within three months prior to randomization
- Subjects who are breastfeeding
- Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
- Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Hamilton, Ontario, L8N 4A6
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H3A 1A1
Study site
Ottawa, Ontario, K1H 7W9
Study site
Québec, Quebec, G1R 2J6
Study site
Saskatoon, Saskatchewan, S7M 0Z9
Study site
Toronto, Ontario, M5C2T2
Study site
Toronto, Ontario, M5G 2N2
Study site
Vancouver, British Columbia, V5Z 1C6
Study site
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus, mycophenolate mofetil, Prednisone
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
IV
Also called Cellcept
IV
PrednisoneDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Steroid rapid 5-day withdrawal Receives: Drug: Tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone |
| 2 | Active comparator | Standard steroid maintenance Receives: Drug: Tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
Measured: 3 months post transplant
Secondary outcomes (2)
Biopsy proven chronic allograft nephropathy(CAN)
Measured: 2 years post transplant
Patient and graft survival rates
Measured: End of study (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Varience of supply chain from that required by protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 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
- Medical Monitor, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133172
- Sponsor's protocol ID
- FKC-011
- Status last verified
- Sep 2014
- First submitted
- 22 Aug 2005
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation
- ClinicalTrials.gov ID
- NCT00133172
- Acronym / sponsor ID
- FKC-011
- Conditions
- Kidney Transplantation
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Varience of supply chain from that required by protocol
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Aug 2005 (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 the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tacrolimus, Drug: mycophenolate mofetil, Drug: PrednisoneSteroid rapid 5-day withdrawal |
| 2 | Active comparator | Drug: Tacrolimus, Drug: mycophenolate mofetil, Drug: PrednisoneStandard steroid maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
- Subject is 18 years of age or over at the time of transplant.
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Key exclusion criteria (11 listed)
- Recipients of a kidney from a donor 60 years of age or older
- Recipients of donation after cardiac death (DCD) donors
- Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
- Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
- Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
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: Prograf, FK506IV | Drug | 1, 2 |
| mycophenolate mofetilAlso: CellceptIV | Drug | 1, 2 |
| PrednisoneIV | Drug | 1, 2 |
Primary outcome
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
Time frame: 3 months post transplant
2 secondary outcomes
Biopsy proven chronic allograft nephropathy(CAN)
Time frame: 2 years post transplant
Patient and graft survival rates
Time frame: End of study (5 years)
Results and safety
The study was stopped early (reason given: Varience of supply chain from that required by protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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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.
Medical Monitor study director
Astellas Pharma Canada, Inc.
14 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, mycophenolate mofetil and Prednisone in people with Kidney Transplantation, run by Astellas Pharma Inc at 14 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 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 14 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 was stopped early (reason given: Varience of supply chain from that required by protocol). Results are not available in the source record.
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?
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR) (time frame: 3 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2014.