Kidney TransplantationPhase 3NCT00141804
Efficacy and Safety of Sirolimus in Combination With Tacrolimus
A Phase 3 study testing Sirolimus in people with Kidney Transplantation, run by University Hospital Muenster at 1 site in Germany.
Trial summary
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Sirolimus
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first kidney transplantation
- re-transplantation
- non-related living donor transplantation
- patients > 18 years
- patients have given their written consent after being informed
- female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test
Who cannot join
- related living donation
- patients with known HIV-anamnesis
- patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
- patients with present malignant disease
- patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
- patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
- other reasons which depend on the assessment of the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation
Read the detailed description
Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.
- Conditions
- Kidney Transplantation
- Being tested
- Sirolimus
- Keywords
- renal transplantation, immunosuppression, prevention of acute rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- time to first biopsy proven acute rejection episode at month 12
- graft failure at month 12
- discontinuation of study medication at month 12
Secondary outcomes (5)
- patient and graft survival at month 12
- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
- incidence and severity of infections at month 12
- incidence of adverse events at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJan 2002
- Study completionJun 2005
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Proverum GmbH, KKS Netzwerk, Fujisawa GmbH
- Investigators
- Heiner H. Wolters, Dr. med., Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141804
- Sponsor's protocol ID
- SirTac 01
- Other IDs
- contract number DE-02-RG-74
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation
- ClinicalTrials.gov ID
- NCT00141804
- Acronym / sponsor ID
- SirTac 01
- Conditions
- Kidney Transplantation
- Keywords
- renal transplantation, immunosuppression, prevention of acute rejection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Proverum GmbH, KKS Netzwerk, Fujisawa GmbH
- Study start
- Jan 2002
- Study completion
- Jun 2005
- First posted
- 1 Sep 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.
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation
Detailed description
Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- first kidney transplantation
- re-transplantation
- non-related living donor transplantation
- patients > 18 years
- patients have given their written consent after being informed
Key exclusion criteria (7 listed)
- related living donation
- patients with known HIV-anamnesis
- patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
- patients with present malignant disease
- patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
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 |
|---|---|---|
| Sirolimus | Drug | – |
Primary outcome
- time to first biopsy proven acute rejection episode at month 12
- graft failure at month 12
- discontinuation of study medication at month 12
5 secondary outcomes
- patient and graft survival at month 12
- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
- incidence and severity of infections at month 12
- incidence of adverse events at month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2005.
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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.
Heiner H. Wolters, Dr. med. principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sirolimus in people with Kidney Transplantation, run by University Hospital Muenster at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 1 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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?
- time to first biopsy proven acute rejection episode at month 12. The study lists 3 primary outcomes in all. 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 1 Dec 2005.