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

NCT02314312 | Unknown Phase 3 DMC

• 1 other identifier: CRAD001ATH01T
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Transplantation of Kidney; Expanded Criteria Donor; ECD

Keywords

Kidney transplantation; ECD

Outcome Measures

Primary Outcomes (1)

• eGFR (CKD-EPI)

  12 months post kidney transplantation

Study Arms (2)

A: investigation arm

EXPERIMENTAL

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

OTHER

De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen

Drug: Standard immunosupressive regimen

Interventions

Everolimus + low dose cyclosporin A + prednisolone DRUG

A: investigation arm

Standard immunosupressive regimen DRUG

B: control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Recipients of first DDKT from ECD or AKI donors
• Patient willing to participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Interventions

Everolimus; Cyclosporine; Prednisolone

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Surasak Kantachuvesiri, M.D., PH.D

  Ramathibodi Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ramathibodi Hospital

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 11, 2014

Record last verified: 2014-12