Organ Transplantation, Renal TransplantationPhase 3CERTES02NCT00154284
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
A Phase 3 study testing Everolimus (Certican), Cyclosporine (Neoral) and Steroid in people with Organ Transplantation, Renal Transplantation, run by Novartis.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Organ Transplantation, Renal Transplantation
- What is being tested?
- Everolimus (Certican), Cyclosporine (Neoral) and Steroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Jul 2008
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
- Renal cold ischemic time < 36 hours.
- Age of donor < 65 years.
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 any organ other than kidney.
- Recipients of non-heart beating donor organs.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
Read the detailed description
This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.
- Being tested
- Everolimus (Certican), Cyclosporine (Neoral), Steroid, Basiliximab (Simulect)
- Keywords
- Renal transplantation,, everolimus,, immunosuppressants,, basiliximab,, cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (Certican)Drug
Also called Certican
Cyclosporine (Neoral)Drug
Also called Neoral
SteroidDrug
Also called Prednisone
Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
Basiliximab (Simulect)Drug
Also called Simulect
| Study group | Role | What they receive |
|---|---|---|
| Everolimus (Certican) with Cyclosporine (Neoral) Continuation | Active comparator | Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. Receives: Drug: Everolimus (Certican); Drug: Cyclosporine (Neoral); Drug: Steroid; Drug: Basiliximab (Simulect) |
| Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal | Experimental | Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. Receives: Drug: Everolimus (Certican); Drug: Cyclosporine (Neoral); Drug: Steroid; Drug: Basiliximab (Simulect) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
Nankivell's formula for calculated GFR is shown below:
GFR [mL/min] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min].
Measured: At Month 3 and Month 12
Secondary outcomes (3)
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.
Measured: Month 12
Serum Creatinine at Month 6 and 12
serum creatinine summarized by mean and standard deviation
Measured: 6 month and 12 months
Calculated Creatinine Clearance at 6 Month and 12 Month
Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:
CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female.
Measured: 6 month and 12 months
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 startJul 2005
- Primary completionJul 2008
- Study completionJul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ Transplantation, Renal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154284
- Sponsor's protocol ID
- CRAD001A2419
- Other IDs
- CRAD001A2423
- Acronym
- CERTES02
- Status last verified
- Jul 2018
- First submitted
- 8 Sep 2005
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Grinyo JM, Paul J, Novoa P, et al. (2010). Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation, Am J Transplant; 10(Suppl 4): 503: Abstract 1636.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00154284
- Acronym / sponsor ID
- CERTES02 / CRAD001A2419
- Keywords
- Renal transplantation,, everolimus,, immunosuppressants,, basiliximab,, cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 11 Mar 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 the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
Detailed description
This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus (Certican) with Cyclosporine (Neoral) Continuation | Active comparator | Drug: Everolimus (Certican), Drug: Cyclosporine (Neoral), Drug: Steroid, Drug: Basiliximab (Simulect)Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. |
| Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal | Experimental | Drug: Everolimus (Certican), Drug: Cyclosporine (Neoral), Drug: Steroid, Drug: Basiliximab (Simulect)Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
- Renal cold ischemic time < 36 hours.
- Age of donor < 65 years.
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 any organ other than kidney.
- Recipients of non-heart beating donor organs.
- 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 (Certican)Also: Certican | Drug | Everolimus (Certican) with Cyclosporine (Neoral) Continuation, Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal |
| Cyclosporine (Neoral)Also: Neoral | Drug | Everolimus (Certican) with Cyclosporine (Neoral) Continuation, Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal |
| SteroidAlso: PrednisoneEach patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. | Drug | Everolimus (Certican) with Cyclosporine (Neoral) Continuation, Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal |
| Basiliximab (Simulect)Also: Simulect | Drug | Everolimus (Certican) with Cyclosporine (Neoral) Continuation, Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal |
Primary outcome
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
Time frame: At Month 3 and Month 12
Nankivell's formula for calculated GFR is shown below: GFR [mL/min] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min].
3 secondary outcomes
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Time frame: Month 12
Serum Creatinine at Month 6 and 12
Time frame: 6 month and 12 months
Calculated Creatinine Clearance at 6 Month and 12 Month
Time frame: 6 month and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGrinyo JM, Paul J, Novoa P, et al. (2010). Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation, Am J Transplant; 10(Suppl 4): 503: Abstract 1636.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus (Certican), Cyclosporine (Neoral) and Steroid in people with Organ Transplantation, Renal Transplantation, run by Novartis.
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 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 9 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 11 Mar 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?
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) (time frame: At Month 3 and Month 12). 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 NCT00154284, 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 9 Aug 2018.