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Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors

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ClinicalTrials.gov Identifier: NCT02314312
Recruitment Status : Unknown
Verified December 2014 by CHALERMPON NA PETVICHARN, Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
CHALERMPON NA PETVICHARN, Mahidol University

Brief 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 transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation

Condition or disease Intervention/treatment Phase
Transplantation of Kidney Expanded Criteria Donor ECD Drug: Everolimus + low dose cyclosporin A + prednisolone Drug: Standard immunosupressive regimen Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: investigation arm
De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen
Drug: Everolimus + low dose cyclosporin A + prednisolone
B: control arm
De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen
Drug: Standard immunosupressive regimen



Primary Outcome Measures :
  1. eGFR (CKD-EPI) [ Time Frame: 12 months post kidney transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314312


Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Surasak Kantachuvesiri, M.D., PH.D Ramathibodi Hospital, Mahidol University

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Responsible Party: CHALERMPON NA PETVICHARN, Ramathibodi Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT02314312     History of Changes
Other Study ID Numbers: CRAD001ATH01T
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by CHALERMPON NA PETVICHARN, Mahidol University:
Kidney transplantation
ECD

Additional relevant MeSH terms:
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Sirolimus
Cyclosporine
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Everolimus
Cyclosporins
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antiemetics