Kidney TransplantationPhase 3DISTAMPNCT00693381
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
A Phase 3 study testing Tacrolimus, Mycophenolate Mofetil and methylprednisolone and prednisone in people with Kidney Transplantation, run by Astellas Pharma Inc at 14 sites in 4 countries.
Trial summary
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose. 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 methylprednisolone and prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Feb 2003to Aug 2004
- Phase
- Phase 3
- 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
- Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type
Who cannot join
- Patient has an immunological high risk, defined as having a most recently measured PRA grade of >= 50% within the previous six months
- Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
- Patient is receiving a graft from a non-heart-beating donor
- Cold ischemia time of the donor kidney >= 40 hours
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Poland7 sites
Study site
Bialystok
Study site
Gdansk
Study site
Krakow
Study site
Lublin
Study site
Warsaw
Study site
Wroclaw
Study site
Zabrze
Czechia4 sites
Study site
Brno
Study site
Hradec Králové
Study site
Olomouc
Study site
Ostrava
About this study
Official title: An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus, Mycophenolate Mofetil, methylprednisolone and prednisone
- Keywords
- Transplantation, Graft Rejection, Renal Transplantation
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
Also called CellCept
oral
methylprednisolone and prednisoneDrug
Also called Steroids
IV and oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tacrolimus/MMF/steroids throughout the study Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: methylprednisolone and prednisone |
| 2 | Experimental | Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3 Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: methylprednisolone and prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
Measured: 6 months
Secondary outcomes (1)
Incidence and seriousness of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startFeb 2003
- Primary completionAug 2004
- Study completionAug 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693381
- Sponsor's protocol ID
- FG-506-02-CEE-01
- Acronym
- DISTAMP
- Status last verified
- Sep 2014
- First submitted
- 3 Jun 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x.
PubMed 17291216
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
- An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00693381
- Acronym / sponsor ID
- DISTAMP / FG-506-02-CEE-01
- Conditions
- Kidney Transplantation
- Keywords
- Transplantation, Graft Rejection, Renal Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 9 Jun 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.
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.
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: Mycophenolate Mofetil, Drug: methylprednisolone and prednisoneTacrolimus/MMF/steroids throughout the study |
| 2 | Experimental | Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: methylprednisolone and prednisoneTacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type
Key exclusion criteria (8 listed)
- Patient has an immunological high risk, defined as having a most recently measured PRA grade of >= 50% within the previous six months
- Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
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 |
| Mycophenolate MofetilAlso: CellCeptoral | Drug | 1, 2 |
| methylprednisolone and prednisoneAlso: SteroidsIV and oral | Drug | 1, 2 |
Primary outcome
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
Time frame: 6 months
1 secondary outcome
Incidence and seriousness of adverse events
Time frame: 6 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 17291216Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x.
Related trials for Kidney 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 Europe B.V.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus, Mycophenolate Mofetil and methylprednisolone and prednisone in people with Kidney Transplantation, run by Astellas Pharma Inc at 14 sites in 4 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 8 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 14 sites in Poland, Czechia, Hungary, Slovakia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation (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 NCT00693381, 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.