Hepatitis C in Renal Transplant Recipients

Renal Transplantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02108301
• Other study ID #: EK477/2011
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 1, 2014
• Last updated: April 10, 2014
• Start date: December 2011

Study information

• Verified date: April 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C-virus Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Renal Transplantation
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Alice Schmidt

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum creatinine levels		12 weeks	Yes
Other	serum glutamic-pyruvic transaminase concentrations		12 weeks	Yes
Primary	change in Hepatitis C-virus load at 12 weeks		one day before and 4, 8 and 12 weeks after the conversion	No
Secondary	change in oral glucose insulin sensitivity (OGIS) index at 12 weeks		one day before and 12 weeks after the conversion	No
Secondary	change in serum hepcidin levels at 12 weeks		one day before and 12 weeks after the conversion	No