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Hepatitis C in renal transplant recipients – Safety and efficacy of a conversion of immunosuppression to high-dose cyclosporine A and its impact on HCV-replication, parameters of liver function and glucose tolerance. An open label trial.

Hepatitis C in renal transplant recipients – Safety and efficacy of a conversion of immunosuppression to high-dose cyclosporine A and its impact on HCV-replication, parameters of liver function and glucose tolerance. An open label trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002267-26-AT
Enrollment
50
Registered
2012-03-19
Start date
2012-04-12
Completion date
Unknown
Last updated
2018-02-26

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

Conditions

renal transplant recipients with hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10057394 Term: Hepatitis C positive System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Sandimmun Neoral 25 mg Product Name: cyclosporine A Pharmaceutical Form: Capsule, soft INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentration unit: mg milligram(s) Concentra

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Written informed consent - Prior renal transplantation with a current tacrolimus-based immunosuppressive regimen - Hepatitis C-infection - Age 18-70 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Current hemodialysis or peritoneal dialysis - Pregnancy or breastfeeding - Known CsA-intolerance

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the impact of a conversion to a cyclosporine A-based immunosuppressive regimen on HCV-replication and parameters of liver function in renal transplant recipients ;Secondary Objective: To assess the impact of a conversion to a cyclosporine A-based immunosuppressive regimen on parameters of insulin sensitivity and insulin secretion in renal transplant recipients ;Primary end point(s): HCV-RNA;Timepoint(s) of evaluation of this end point: 12 weeks after the conversion of immunosuppression from a tacrolimus- to a cyclosporine a-based regimen—

Secondary

MeasureTime frame
Secondary end point(s): liver transaminases, fibroScan-Indices, IL28-SNP, vitamin D, parameters of insulin sensitivity and insulin secretion, plasma adipokine levels ;Timepoint(s) of evaluation of this end point: 12 weeks after the conversion of immunosuppression from a tacrolimus- to a cyclosporine a-based regimen—

Countries

Austria

Contacts

Public ContactAmmon Handisurya

Medizinische Universität Wien

ammon.handisurya@meduniwien.ac.at00431404004495

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026