Kidney TransplantationPhase 4NCT00170885
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
A Phase 4 study testing Everolimus in people with Kidney Transplantation, run by Novartis at 1 site in Switzerland.
Trial summary
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Everolimus
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- May 2005to Jul 2007
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
- The renal cold ischemic time must be < 36 hours.
- The age of the donor must be between 15 and 65 years.
Who cannot join
- Patients who are recipients of multiple organ transplants, including more than one kidney
- Patients who have previously received an organ transplant which failed within one year
- Patients with current panel reactive T-cell antibody titers of 50% or more
- Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
- Conditions
- Kidney Transplantation
- Being tested
- Everolimus
- Keywords
- acute rejection, renal function, everolimus, cyclosporine microemulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
Secondary outcomes (5)
Pharmacokinetics (PK)
Count of CD4 and CD8 positive lymphocytes
Metabolic control: lipids, glycaemic control, proteinuria, enzymes
Ultrasound ejection fraction
Major adverse cardiovascular events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2007
- Study completionJul 2007
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170885
- Sponsor's protocol ID
- CRAD001AIT02
- Status last verified
- Nov 2016
- First submitted
- 9 Sep 2005
- Last updated
- 16 Nov 2016
- Results posted
- No
Publications
Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, Bartezaghi M; EVEREST Study. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation. 2011 May 27;91(10):e72-3. doi: 10.1097/TP.0b013e318216c1db. No abstract available.
PubMed 21540717
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00170885
- Acronym / sponsor ID
- CRAD001AIT02
- Conditions
- Kidney Transplantation
- Keywords
- acute rejection, renal function, everolimus, cyclosporine microemulsion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 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.
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
- The renal cold ischemic time must be < 36 hours.
- The age of the donor must be between 15 and 65 years.
Key exclusion criteria (5 listed)
- Patients who are recipients of multiple organ transplants, including more than one kidney
- Patients who have previously received an organ transplant which failed within one year
- Patients with current panel reactive T-cell antibody titers of 50% or more
- Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Everolimus | Drug | – |
Primary outcome
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
5 secondary outcomes
Pharmacokinetics (PK)
Count of CD4 and CD8 positive lymphocytes
Metabolic control: lipids, glycaemic control, proteinuria, enzymes
Ultrasound ejection fraction
Major adverse cardiovascular events
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 16 Nov 2016.
- Results publication: PubMed 21540717Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, Bartezaghi M; EVEREST Study. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation. 2011 May 27;91(10):e72-3. doi: 10.1097/TP.0b013e318216c1db. No abstract available.
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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.
Novartis study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus in people with Kidney Transplantation, run by Novartis at 1 site in Switzerland.
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 5 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 16 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 1 site in Switzerland. 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 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?
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment. 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 NCT00170885, 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 16 Nov 2016.