Kidney TransplantationPhase 4NCT00885820
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
A Phase 4 study testing Tacrolimus, MMF and Corticosteroids (Prednisone) in people with Kidney Transplantation, run by Astellas Pharma Inc at 12 sites in 2 countries.
Trial summary
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group. 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, MMF and Corticosteroids (Prednisone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Sep 2001to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal 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 over 65 years of age
- Recipient of non-related donor kidney with peak pre-transplant PRA > 50
- Subject has lost a previous graft to rejection less than one year from transplant
- Subject who has received an investigational drug within three months prior to randomization
- Subjects who are pregnant or breastfeeding
- Subject receives a kidney lacking a pre-implantation biopsy
- Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada11 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Hamilton, Ontario, L8N 4A6
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H2L 4M1
Study site
Ottawa, Ontario, K1H 7W9
Study site
Québec, Quebec, G1R 2J6
Study site
Saskatoon, Saskatchewan, S7M 0Z9
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Vancouver, British Columbia, V6Z 1Y6
Study site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Keywords
- Kidney Transplantation, Tacrolimus, Immunosuppression, Graft Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
Oral
MMFDrug
Also called Cellcept
Oral
Corticosteroids (Prednisone)Drug
Also called Methylprednisolone, Prednisone
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Protocol biopsies at 1, 2 and 3 months Receives: Drug: Tacrolimus; Drug: MMF; Drug: Corticosteroids (Prednisone) |
| 2 | Active comparator | No protocol biopsies Receives: Drug: Tacrolimus; Drug: MMF; Drug: Corticosteroids (Prednisone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
Measured: 6 months
Secondary outcomes (3)
The incidence of subclinical rejection at 6 months
Measured: 6 months
Prevalence of chronic renal histopathology at 24 months
Measured: 24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion
Measured: 6, 12 and 24 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startSep 2001
- Primary completionJul 2004
- Study completionJan 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 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
- None (open label)
- Enrolment
- 240 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
- NCT00885820
- Sponsor's protocol ID
- FKC-008
- Status last verified
- Sep 2014
- First submitted
- 20 Apr 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.
PubMed 19935461
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
- The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
- ClinicalTrials.gov ID
- NCT00885820
- Acronym / sponsor ID
- FKC-008
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, Tacrolimus, Immunosuppression, Graft Survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Sep 2001
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 22 Apr 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 multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.
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: Tacrolimus, Drug: MMF, Drug: Corticosteroids (Prednisone)Protocol biopsies at 1, 2 and 3 months |
| 2 | Active comparator | Drug: Tacrolimus, Drug: MMF, Drug: Corticosteroids (Prednisone)No protocol biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Key exclusion criteria (7 listed)
- Recipients of a kidney from a donor over 65 years of age
- Recipient of non-related donor kidney with peak pre-transplant PRA > 50
- Subject has lost a previous graft to rejection less than one year from transplant
- Subject who has received an investigational drug within three months prior to randomization
- Subjects who are pregnant or breastfeeding
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, FK506Oral | Drug | 1, 2 |
| MMFAlso: CellceptOral | Drug | 1, 2 |
| Corticosteroids (Prednisone)Also: Methylprednisolone, PrednisoneOral | Drug | 1, 2 |
Primary outcome
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
Time frame: 6 months
3 secondary outcomes
The incidence of subclinical rejection at 6 months
Time frame: 6 months
Prevalence of chronic renal histopathology at 24 months
Time frame: 24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion
Time frame: 6, 12 and 24 moths
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 19935461Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.
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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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus, MMF and Corticosteroids (Prednisone) in people with Kidney Transplantation, run by Astellas Pharma Inc at 12 sites in 2 countries.
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 2 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 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 12 sites in Canada, United States. 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?
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months (time frame: 6 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 NCT00885820, 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 18 Sep 2014.