?Therapy for chronic HCV-infected? renal transplant patients MedDRA version: 18.0 Level: LLT Classification code 10054990 Term: Immunodeficiency secondary to organ transplantation System Organ Class: 100000004870 MedDRA version: 18.0 Level: LLT Classification code 10002724 Term: Anti-HCV positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Daklinza
Pharmaceutical Form: Film-coated tablet
Trade Name: Sovaldi
Pharmaceutical Form: Film-coated tablet
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. >18 year old renal transplant recipients 2. Renal transplant patients with chronic HCV-infection, Genotyp Ia and Ib with HCV RNA 3. Renal transplant patients with untreated or previously failed treatment of HCV-infection 4. Renal transplant patients with calculated glomerular filtration rate (cGFR) according to the CKD-EPI formula >30ml/min 5. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained 6. Women of childbearing potential (WOCBP) should have a negative pregnancy test (serum or urine) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. WOCBP who is either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test 2. Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption 3. Treatment with any investigational drug within 3 months preceding the study 4. Patient with a history of malignancies in the last 5 years with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma 5. Patients with Co-infection with HIV or HBV 6. Patients with evidence of a medical condition associated with chronic decompensated liver disease (Child-Pugh class B or C) 7. Patients who suffered from severe rejection (= Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrolment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of sustained virologic resonse (SVR) in all treated renal transplant patients at week 12 after the end of treatment. ;Secondary Objective: The proportion of renal transplant patients with a sustained virologic response (HCV-RNA levels <15IU/ml) at week 4 and 24 after the end of treatment. Patient/graft survival at week 12 and 24 after the end of treatment Acute Rejection including incidence, severity, type, treatment including time to event analyses Renal Function as determined by serum creatinine, calculated glomerular filtration rate (cGFR; CKD-EPI formula), the cGFR slope and CKD stages at week 12 and 24 after the end of treatment Change of C0 levels and daily dosing of Calcineurin-Inhibitors Qualitiy TOF urin analysis of drug metabolism Safety including adverse events (AEs) and serious AEs (SAEs), events of special interest: infections, opportunistic infections, malignancies, PTLDs, clinically significant changes in vital signs, clinically significant laboratory test abnormalities including proteinuria Tolerability of treatment regimen including treatment failures and reason for treatment failures ;Primary end point(s): The proportion of renal transplant patients with a sustained virologic response (HCV-RNA levels <15IU/ml) at week 12 after the end of treatment. ;Timepoint(s) of evaluation of this end point: 12 weeks after end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of renal transplant patients with a sustained virologic response (HCV-RNA levels <15IU/ml) at week 4 and 24 after the end of treatment. 2. Patient and graft survival at week 12 and 24 after the end of treatment 3. Acute Rejection (BPAR and treated), including incidence, severity (according to Banff grades), type (T-cell mediated, and antibody mediated), treatment (steroid resistant rejection, antibody treated rejection, rejection requiring conversion of baseline immunosuppressant) including time to event analyses 4. Renal Function as determined by serum creatinine, calculated glomerular filtration rate (cGFR) according to the CKD-EPI formula, the cGFR slope and different CKD stages at week 12 and 24 after the end of treatment 5. Change of C0 levels and daily dosing of Calcineurin-Inhibitors 6. Qualitiy TOF urin analysis of drug metabolism 7. Proportion of Safety events of the treatment regimen including adverse events (AEs) and serious AEs (SAEs), events of special interest: infections, opportunistic infections, malignancies, PTLDs, clinically significant changes in vital signs, clinically significant laboratory test abnormalities including proteinuria 8. Proportion of patients with treatment failures (virus breakthrough and relapse) ;Timepoint(s) of evaluation of this end point: week 4, 12, 24 after treatment | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Charité Universitätsmedizin Berlin
Outcome results
None listed