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Hepatitis C in Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02108301
Recruitment Status : Unknown
Verified April 2014 by Prof. Dr. Alice Schmidt, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Alice Schmidt, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C-virus Infection Renal Transplantation Drug: tacrolimus-cyclosporine A Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2011
Actual Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tacrolimus-cyclosporine A
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
Drug: tacrolimus-cyclosporine A
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients




Primary Outcome Measures :
  1. change in Hepatitis C-virus load at 12 weeks [ Time Frame: one day before and 4, 8 and 12 weeks after the conversion ]

Secondary Outcome Measures :
  1. change in oral glucose insulin sensitivity (OGIS) index at 12 weeks [ Time Frame: one day before and 12 weeks after the conversion ]
  2. change in serum hepcidin levels at 12 weeks [ Time Frame: one day before and 12 weeks after the conversion ]

Other Outcome Measures:
  1. serum creatinine levels [ Time Frame: 12 weeks ]
  2. serum glutamic-pyruvic transaminase concentrations [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108301


Locations
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Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Vienna, Austria, 1090
Sponsors and Collaborators
Prof. Dr. Alice Schmidt

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Alice Schmidt, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02108301     History of Changes
Other Study ID Numbers: EK477/2011
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014
Keywords provided by Prof. Dr. Alice Schmidt, Medical University of Vienna:
chronic hepatitis C-virus infection
renal transplantation
glucose tolerance
immunosuppression
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cyclosporine
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents