Kidney de Novo TransplantPhase 3NCT00238992
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney de Novo Transplant, run by Novartis Pharmaceuticals.
Trial summary
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney de Novo Transplant
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Jul 2005
- 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female patients undergoing first kidney transplant.
- Patients aged 18 -70 years.
- Patients receiving an ABO identical or compatible graft. Exclusion Criteria
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
- Positive HBsAg test
- Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.
Who cannot join
None listed.
About this study
Official title: A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.
- Conditions
- Kidney de Novo Transplant
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-coated Mycophenolate sodium (EC-MPS)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy proven acute rejection incidence at 1 year post-transplantation
Secondary outcomes (7)
Incidence of biopsy proven acute rejection episodes at 6 months
Incidence of treated rejection episodes at 6 months and 1 year
Incidence of steroid-resistant episodes at 6 months and 1 year
Patient and graft survival at 1 year
Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
Percentage of patients free from steroids at 6 months and 1 year
Treatment safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startDec 2002
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney de Novo TransplantStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238992
- Sponsor's protocol ID
- CERL080A2405ES01
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2005
- Last updated
- 2 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.
- ClinicalTrials.gov ID
- NCT00238992
- Acronym / sponsor ID
- CERL080A2405ES01
- Conditions
- Kidney de Novo Transplant
- Keywords
- Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2005 (actual)
- First posted
- 14 Oct 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.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients undergoing first kidney transplant.
- Patients aged 18 -70 years.
- Patients receiving an ABO identical or compatible graft. Exclusion Criteria
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
- Positive HBsAg test
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS) | Drug | – |
Primary outcome
biopsy proven acute rejection incidence at 1 year post-transplantation
7 secondary outcomes
Incidence of biopsy proven acute rejection episodes at 6 months
Incidence of treated rejection episodes at 6 months and 1 year
Incidence of steroid-resistant episodes at 6 months and 1 year
Patient and graft survival at 1 year
Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
Percentage of patients free from steroids at 6 months and 1 year
Treatment safety
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 2 Nov 2011.
Related trials for Kidney de Novo Transplant
Not yet recruitingPhase 3
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
Kidney Transplant Rejection
RecruitingPhase 4
Extended-Release Tacrolimus Following Liver Transplantation
Liver Transplant; Complications, Renal Insufficiency
Not yet recruitingPhase 2/3
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)
Kidney Transplant Rejection
Active, not recruitingPhase 1
Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study
Kidney Transplant, Renal Transplant Recipients
RecruitingPhase 1/2
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Ischemia Reperfusion Injury, Delayed Graft Function
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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney de Novo Transplant, run by Novartis Pharmaceuticals.
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 6 inclusion and 0 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
biopsy proven acute rejection incidence at 1 year post-transplantation. 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 2011.