Renal TransplantationPhase 4NCT00154297
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
A Phase 4 study testing Everolimus (RAD001) in people with Renal Transplantation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Everolimus (RAD001)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2005to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Recipients of cadaveric kidney transplants
- Patients at risk of DGF defined as one or more of the following:
- Donor age > 55 years
- Cold ischemic time (CIT) ≥ 24 hours but < 40 hours
- Second or subsequent renal transplantation
Who cannot join
- Patients who have received an investigational drug within 4 weeks of baseline period
- Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
- Patients with body mass index (BMI) > 32 kg/m2
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.
- Conditions
- Renal Transplantation
- Being tested
- Everolimus (RAD001)
- Keywords
- Renal transplantation, everolimus, immunosuppressants, wound-healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (RAD001)Drug
| Study group | Role | What they receive |
|---|---|---|
| Immediate Everolimus | Active comparator | Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Receives: Drug: Everolimus (RAD001) |
| Delayed Everolimus | Experimental | Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. Receives: Drug: Everolimus (RAD001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
"In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).
Measured: Month 3
Secondary outcomes (5)
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months:
- delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
- efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
- wound healing disorder related to initial transplant surgery
Measured: at 6 Month post-transplantation
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months:
- delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
- efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
- wound healing disorder related to initial transplant surgery
Measured: at 12 Month post-transplantation
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
The number of patients who underwent any dialysis within the 12-month treatment period.
Measured: Month 12
Duration of Dialysis
The mean duration in days of any dialysis session that occurred within the 12 month treatment period.
Measured: 12 months
Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal TransplantationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154297
- Sponsor's protocol ID
- CRAD001A2420
- Status last verified
- Mar 2011
- First submitted
- 8 Sep 2005
- Last updated
- 4 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function
- ClinicalTrials.gov ID
- NCT00154297
- Acronym / sponsor ID
- CRAD001A2420
- Conditions
- Renal Transplantation
- Keywords
- Renal transplantation, everolimus, immunosuppressants, wound-healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 26 Jan 2011
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 this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Everolimus | Active comparator | Drug: Everolimus (RAD001)Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. |
| Delayed Everolimus | Experimental | Drug: Everolimus (RAD001)Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recipients of cadaveric kidney transplants
- Patients at risk of DGF defined as one or more of the following:
Key exclusion criteria (4 listed)
- Patients who have received an investigational drug within 4 weeks of baseline period
- Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
- Patients with body mass index (BMI) > 32 kg/m2
- 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 (RAD001) | Drug | Delayed Everolimus, Immediate Everolimus |
Primary outcome
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Time frame: Month 3
"In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).
5 secondary outcomes
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Time frame: at 6 Month post-transplantation
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Time frame: at 12 Month post-transplantation
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
Time frame: Month 12
Duration of Dialysis
Time frame: 12 months
Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Renal Transplantation
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
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 (RAD001) in people with Renal Transplantation, run by Novartis Pharmaceuticals 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 5 inclusion and 4 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 4 Apr 2011. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months (time frame: Month 3). 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 4 Apr 2011.