Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection.

The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen.

The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Male or female renal transplant recipients 18-75 years of age (primary or re-transplant)

• Recipients of cadaveric, living unrelated or living related donor kidney

• Baseline immunosuppression (IS) consisting of tacrolimus, MPA, and prednisone

• Patients with BK viruria ≥ 1 million copies/mL and/or viremia (> 500 copies/mL) found on routine BKV screening.

• Patients who have given written informed consent to participate in the study

Exclusion Criteria:

• Patients who are ABO incompatible transplants

• Patients with an abnormal liver profile such as Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or total bilirubin > 3x ULN at the time of randomization

• Patients with severe total hypercholesterolemia (> 350 mg/dL) or total hypertriglyceridemia (> 500 mg/dL). Patients on lipid lowering drugs with controlled hyperlipidemia are acceptable.

• Patients with a platelet count < 100,000/mm3 at randomization

• Patients with an ANC < 1,500/mm3 or WBC < 4.5mm3

• Patients with a known hypersensitivity to the study drug or to drugs of similar chemical classes.

• Patients being treated with drugs (other than tacrolimus) that are potent inducers or inhibitors of cytochrome P4503A4

• Patients who have any surgical or medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled DM, which, in the opinion of the investigators, might significantly alter the absorption, distribution, metabolism and/or excretion of study medication.

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine human chorionic gonadotrophin laboratory test

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

• Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

• Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.

• Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.

• Patients with baseline urine protein excretion > 500mg/day

• Patients with Estimated Glomerular Filtration Rate (eGFR) < 40 ml/min

• Patients who have undergone desensitization