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

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus

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.