Heart TransplantationPhase 4NCT00121784
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
A Phase 4 study testing mycophenolate mofetil [CellCept] in people with Heart Transplantation, run by Hoffmann-La Roche at 29 sites in 6 countries.
Trial summary
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- mycophenolate mofetil [CellCept]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Oct 2005to Aug 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
- adult (>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
- receipt of first heart (single-organ) transplant;
- standard care regimen of CNI, MMF, and corticosteroids since transplantation.
Who cannot join
- positive donor-specific cross-match at time of transplantation;
- history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
- patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States11 sites
Study site
Boston, Massachusetts, 02115
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75230
Study site
Detroit, Michigan, 48202-2689
Study site
Maywood, Illinois, 60153
Study site
Memphis, Tennessee, 38120
Study site
Minneapolis, Minnesota, 55455
Study site
Philadelphia, Pennsylvania, 19102
Study site
Salt Lake City, Utah, 84148
France8 sites
Study site
Marseille, 13385
Study site
Nantes, 44093
Study site
Paris, 75651
Study site
Paris, 75908
Study site
Rennes, 35033
Study site
Rouen, 76031
Study site
Tours, 37044
Study site
Vandœuvre-lès-Nancy, 54511
Germany4 sites
Study site
Berlin, 13353
Study site
Hanover, 30625
Study site
Heidelberg, 69120
Study site
Jena, 07740
Australia3 sites
Study site
Darlinghurst, 2010
Study site
Perth, 6847
Study site
Prahran, 3181
About this study
Official title: A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
- Conditions
- Heart Transplantation
- Being tested
- mycophenolate mofetil [CellCept]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate mofetil [CellCept]Drug
1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 Receives: Drug: mycophenolate mofetil [CellCept] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n
Secondary outcomes (1)
Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121784
- Sponsor's protocol ID
- MT18328
- Status last verified
- Nov 2016
- First submitted
- 15 Jul 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients
- ClinicalTrials.gov ID
- NCT00121784
- Acronym / sponsor ID
- MT18328
- Conditions
- Heart Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Jul 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.
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate mofetil [CellCept]1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
- receipt of first heart (single-organ) transplant;
- standard care regimen of CNI, MMF, and corticosteroids since transplantation.
Key exclusion criteria (3 listed)
- positive donor-specific cross-match at time of transplantation;
- history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
- patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
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 |
|---|---|---|
| mycophenolate mofetil [CellCept]1 | Drug | 1 |
Primary outcome
Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n
1 secondary outcome
Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study chair
Hoffmann-La Roche
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mycophenolate mofetil [CellCept] in people with Heart Transplantation, run by Hoffmann-La Roche at 29 sites in 6 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 3 inclusion and 3 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Germany, Australia, Spain and 1 more country. 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: Poor recruitment). 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?
Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n. 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 2 Nov 2016.