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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01469884
• Date of registration: 01/11/2011
• Primary sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Public title: Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients CONCERVIC
• Scientific title: A Prospective, Single-center, Open-label, Pilot Study to Investigate the Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients.
• Date of first enrolment: November 2011
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01469884
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

Brazil

Contacts

• Name: VALTER D GARCIA, PHYSICIAN

• Name: Valter Garcia, Physician

• Name: BRUNA D CARDOSO, PHARMACIST
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: DIEGO GNATTA, PHARMACIST
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: ELIZETE KEITEL, Physician
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: LARISSA S PACHECO, PHARMACIST
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: MARIANA F RODRIGUES, PHARMACIST
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: RONIVAN L DAL PRA, PHARMACIST
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

• Name: Valter Garcia, Physician
• Affiliation: IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Renal Allograft

Intervention(s)

Drug: Cyclosporine

Drug: Everolimus

Drug: Tacrolimus

Primary Outcome(s)

Change from baseline in viral load of hepatitis C virus at 12 months after randomization. [Time Frame: Baseline,Months 3, 6, 9 and 12 after randomization]

Secondary Outcome(s)

Development of dyslipidemia [Time Frame: Months 1, 3, 6, 9 and 12 after randomization]

Development of hypertension [Time Frame: Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization]

Development of liver impairment [Time Frame: Months 1, 3, 6, 9, and 12 after randomization]

Development of malignance [Time Frame: Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization]

Development of post-transplant diabetes [Time Frame: Months 1, 3, 6, 9 and 12]

Development of proteinuria [Time Frame: Months 1, 3, 6, 9 and 12 after randomization]

Graft loss survival [Time Frame: Weeks 1, 2 , 3 and months 1, 3 ,6, 9 and 12 after randomization]

Incidence of acute allograft rejection [Time Frame: Weeks 1, 2, 3, months 1, 3, 6, 9 and 12 after randomization]

Incidence of significant infections [Time Frame: Weeks1, 2, 3 and months 1, 3, 6,9 and 12 after randomization]

Patient survival [Time Frame: Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization]

Secondary ID(s)

CRAD001

CRAD001ABR20T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis