Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare the viral load of hepatitis c virus in patients converted to certican versus patients who are maintained on calcineurin inhibitor.

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

Details

• Lead Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Collaborator: Novartis
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion criteria

• Age ≥ 18 years at the time of screening;

• Subjects between the first and tenth year after renal transplantation;

• Subjects with positive serology for hepatitis C;

• Subjects receiving calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate sodium or mofetil plus prednisone since the first month post-transplant;

• Subjects with no acute rejection episode in the last 3 month;

• Women of childbearing potential (CBP) with a negative pregnancy test at screening (urine or serum;

• Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study. The investigator will determine which contraceptive method more effective and appropriate for each study subject. Acceptable methods of contraception include oral contraceptives, barrier methods (eg, diaphragm or condom with spermicide) and intrauterine devices.

Exclusion criteria:

• Subjects who, in the opinion of the investigator, are not able to complete the study;

• Recipients of multiple organ transplant (i.e., prior or concurrent transplantation of a non-renal allograft;

• Subjects with a calculated GFR < 30ml/min (abbreviated MDRD formula;

• Subjects with Urinary protein/creatinine > 0.5;

• Renal biopsy with score ≥ Banff grade II interstitial fibrosis and tubular atrophy (Banff 2007;

• Subjects with a history of biopsy-proven acute rejection within 12 weeks of enrollment;

• Known or suspected hypersensitivity to inhibitor of mTOR;

• Subjects with a history of primary or recurrent FSGS, membranous glomerulonephritis (MGN) or membranoproliferative glomerulonephritis (MPGN);

• Evidence of any active systemic or localized major infection;

• Use of any investigational drug or treatment up to 4 weeks before enrollment;

• Immunosuppressive therapies other than those described by this protocol;

• Planned systemic treatment with voriconazole, cisapride or ketoconazole that will not be discontinued before randomization;

• Prior treatment with aminoglycosides, amphotericin B, cisplatin or other drugs associated with renal dysfunction that is not discontinued before screening;

• Subjects with a screening total white blood cell count (WBC) ≤ 2000/mm3, hemoglobin ≤ 10g/dL and platelet count ≤ 100000/mm3;

• TGO/AST, TGP/ALT and bilirubins with values three times higher than reference values;

• Fasting triglycerides ≥ 400 mg/dL, fasting total cholesterol ≥ 350 mg/dL or LDL-cholesterol ≥ 160mg/dL despite the use of optimal lipid-lowering therapy;

• History of malignancy within 3 years before enrollment other than adequately treated basal cell or squamous cell carcinoma of the skin;

• Subjects who are known to be human immunodeficiency virus (HIV) positive or hepatitis B positive;

• Chronic hepatic failure.