Transplantation of KidneyPhase 3NCT02314312
Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors
A Phase 3 study testing Everolimus + low dose cyclosporin A + prednisolone and Standard immunosupressive regimen in people with Transplantation of Kidney and Expanded Criteria Donor, run by Mahidol University.
Trial summary
Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplantation of Kidney, Expanded Criteria Donor, ECD
- What is being tested?
- Everolimus + low dose cyclosporin A + prednisolone and Standard immunosupressive regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Recipients of first DDKT from ECD or AKI donors
- Patient willing to participate in the study
Who cannot join
- Multi-organ recipients
- Organ donation after Cardiac Death (DCD).
- PRA > 20 % or with historical peak PRA > 50%
- Patients who lost first graft due to immunological reason within the first year post-transplantation.
- ABO incompatible transplants or positive cross-match
- Patients with chronic inflammatory bowel disease.
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- Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin
- Thrombocytopenia (platelet < 75,000/mm3), ANC < 1,500 /mm3 or leucopenia (leucocytes < 2,500/mm3), or Hb < 6 g/dL
- Chronic active HCV, HIV, or HBsAg positive
- History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.
- Ongoing infection requiring treatment with a systemic antibiotic.
- Patient with severe hypercholesterolemia (> 300 mg/dL) or hypertriglyceridemia (> 600 mg/dL) that cannot be controlled
- Evidence of severe liver disease.
- Severe restrictive or obstructive pulmonary disorders.
- Pregnant or nursing (lactating) women.
- Patient who refuse to participate into the study or would like to withdraw from the study.
About this study
Official title: A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury
Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation
Read the detailed description
Secondary Endpoints:
- To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation
- To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation
- To assess the incidence and duration of renal replacement therapy
- To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12
- To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation
- To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation
Definition of ECD
- Brain-dead donor > 60 years old or
- Donor age > 50 years old with two of the following criteria;
- History of HT
- Terminal SCr. ≥ 1.5 mg/dL
- Death from cerebrovascular accident Definition of AKI donor
- Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline
- Conditions
- Transplantation of Kidney, Expanded Criteria Donor, ECD
- Being tested
- Everolimus + low dose cyclosporin A + prednisolone, Standard immunosupressive regimen
- Keywords
- Kidney transplantation, ECD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus + low dose cyclosporin A + prednisoloneDrug
Standard immunosupressive regimenDrug
| Study group | Role | What they receive |
|---|---|---|
| A: investigation arm | Experimental | De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen Receives: Drug: Everolimus + low dose cyclosporin A + prednisolone |
| B: control arm | Other | De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen Receives: Drug: Standard immunosupressive regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR (CKD-EPI)
Measured: 12 months post kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation of KidneyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHALERMPON NA PETVICHARN, Mahidol University
- Investigators
- Surasak Kantachuvesiri, M.D., PH.D, Principal investigator, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314312
- Sponsor's protocol ID
- CRAD001ATH01T
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02314312
- Acronym / sponsor ID
- CRAD001ATH01T
- Conditions
- Transplantation of Kidney, Expanded Criteria Donor, ECD
- Keywords
- Kidney transplantation, ECD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 11 Dec 2014 (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.
Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation
Detailed description
Secondary Endpoints:
- To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation
- To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation
- To assess the incidence and duration of renal replacement therapy
- To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12
- To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation
- To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation
Definition of ECD
- Brain-dead donor > 60 years old or
- Donor age > 50 years old with two of the following criteria;
- History of HT
- Terminal SCr. ≥ 1.5 mg/dL
- Death from cerebrovascular accident Definition of AKI donor
- Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: investigation arm | Experimental | Drug: Everolimus + low dose cyclosporin A + prednisoloneDe novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen |
| B: control arm | Other | Drug: Standard immunosupressive regimenDe novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Recipients of first DDKT from ECD or AKI donors
- Patient willing to participate in the study
Key exclusion criteria (16 listed)
- Multi-organ recipients
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 + low dose cyclosporin A + prednisolone | Drug | A: investigation arm |
| Standard immunosupressive regimen | Drug | B: control arm |
Primary outcome
eGFR (CKD-EPI)
Time frame: 12 months post kidney transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Surasak Kantachuvesiri, M.D., PH.D principal investigator
Ramathibodi Hospital, Mahidol University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus + low dose cyclosporin A + prednisolone and Standard immunosupressive regimen in people with Transplantation of Kidney and Expanded Criteria Donor, run by Mahidol University.
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 16 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 11 Dec 2014. 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?
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?
eGFR (CKD-EPI) (time frame: 12 months post kidney transplantation). 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 11 Dec 2014.