Kidney TransplantationPhase 4NCT00507793
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
A Phase 4 study testing Sirolimus and Cyclosporine in people with Kidney Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. 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?
- Sirolimus and Cyclosporine
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Jun 2002
- 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
- At least 18 years of age
- End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
- Patients with secondary kidney transplant must have maintained primary graft for at least 6 months
Who cannot join
- Antibody induction within one week of current transplantation
- Multiorgan transplants
- Patients at high-risk of rejection
About this study
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
Read the detailed description
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.
- Conditions
- Kidney Transplantation
- Being tested
- Sirolimus, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
CyclosporineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
Secondary outcomes (1)
Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startApr 2000
- Study completionJun 2002
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
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507793
- Sponsor's protocol ID
- 0468E1-4351
- Status last verified
- Jul 2007
- First submitted
- 26 Jul 2007
- Last updated
- 27 Jul 2007
- Results posted
- No
Publications
Muhlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.
PubMed 24266855
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
- ClinicalTrials.gov ID
- NCT00507793
- Acronym / sponsor ID
- 0468E1-4351
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Study completion
- Jun 2002 (actual)
- First posted
- 27 Jul 2007 (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 evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
Detailed description
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
- Patients with secondary kidney transplant must have maintained primary graft for at least 6 months
Key exclusion criteria (3 listed)
- Antibody induction within one week of current transplantation
- Multiorgan transplants
- Patients at high-risk of rejection
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 | – |
| Cyclosporine | Drug | – |
Primary outcome
A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
1 secondary outcome
Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.
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 27 Jul 2007.
- Derived from this study: PubMed 24266855Muhlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sirolimus and Cyclosporine in people with Kidney Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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: finished, as of the sponsor's last update on 27 Jul 2007. 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 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?
A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.. 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 NCT00507793, 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 27 Jul 2007.