Hepatitis C in Renal Transplant Recipients

Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02108301

Enrollment

Registered

2014-04-09

Start date

2011-12-31

Completion date

Unknown

Last updated

2014-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C-virus Infection, Renal Transplantation

Keywords

chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression

Brief summary

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.

Interventions

DRUGtacrolimus-cyclosporine A

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
change in Hepatitis C-virus load at 12 weeks	one day before and 4, 8 and 12 weeks after the conversion

Secondary

Measure	Time frame
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks	one day before and 12 weeks after the conversion
change in serum hepcidin levels at 12 weeks	one day before and 12 weeks after the conversion

Other

Measure	Time frame
serum creatinine levels	12 weeks
serum glutamic-pyruvic transaminase concentrations	12 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026