Hepatitis C in Renal Transplant Recipients

Prof. Dr. Alice Schmidt

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis C-virus Infection; Renal Transplantation

Treatments: Drug: tacrolimus-cyclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT02108301

EK477/2011

Details and patient eligibility

About

The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent
• prior renal transplantation
• current tacrolimus-based immunosuppressive regimen
• hepatitis C-infection
• age 18-70 years

Exclusion criteria

• current hemodialysis or peritoneal dialysis
• pregnancy or breastfeeding
• known contraindication for cyclosporine A-treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

tacrolimus-cyclosporine A

Experimental group

Description:

conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients

Treatment:

Drug: tacrolimus-cyclosporine A