- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02314312
Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors
December 10, 2014 updated by: CHALERMPON NA PETVICHARN, Mahidol University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-75 years
- Recipients of first DDKT from ECD or AKI donors
- Patient willing to participate in the study
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: investigation arm
De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen
|
|
Other: B: control arm
De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
eGFR (CKD-EPI)
Time Frame: 12 months post kidney transplantation
|
12 months post kidney transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Surasak Kantachuvesiri, M.D., PH.D, Ramathibodi Hospital, Mahidol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
December 8, 2014
First Submitted That Met QC Criteria
December 10, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Prednisolone
- Everolimus
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CRAD001ATH01T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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