NFLUENCE OF TREATMENT WITH DIRECT ANTIVIRAL AGENTS IN THE GLOMERULAR AND TUBULAR FUNCTION OF PATIENTS WITH CHRONIC HCV HEPATITIS

MULTICENTER CLINICAL TRIAL TO DETERMINE THE INFLUENCE OF TREATMENT WITH DIRECT ANTIVIRAL AGENTS IN THE GLOMERULAR AND TUBULAR FUNCTION OF PATIENTS WITH CHRONIC HCV HEPATITIS - RENAL-AAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005081-60-ES

Enrollment

200

Registered

2017-03-10

Start date

2017-04-21

Completion date

Unknown

Last updated

2018-11-26

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

Conditions

Hepatitis C

Interventions

Trade Name: SOVALDI Product Name: SOFOSBUVIR Pharmaceutical Form: Tablet INN or Proposed INN: SOFOSBUVIR CAS Number: 1190307-88-0 Current Sponsor code: Gilead Other descriptive name: SOFOSBUVIR Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic HCV genotype see above, regardless of the degree of fibrosis, with sofosbuvir / ledipasvir or 3D regimen of Abvvie. Patients should NOT receive ribavirin in their therapeutic regimen. Age greater than 18. Baseline glomerular filtration greater than 30 ml / min. Written informed consent in accordance with ICH / GCP and Spanish legislation obtained before any study procedure. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: -Coinfection with VHD (hepatitis delta virus), HBV (hepatitis C virus) or HIV (human immunodeficiency virus). - Fibroscan> 14 - Evidence of current or previous decompensation (ascites, HDA, encephalopathy). - Diagnosis of CHC (Hepatocellular Carcinoma). - Diagnosis of cryoglobulinemia - Mellitus diabetes - Intake of alcohol equal to or greater than 50 grams of alcohol. - Patients undergoing liver transplantation. - Patients with platelets 2.5. - Use of nephrotoxic agents. - If in the opinion of the researcher there are findings in the physical examination, anomalies in the results of the clinical analyzes or other medical, social or psychosocial factors that could influence negatively. - Have received any investigational drug within 60 days prior to study drug administration. - Inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the potential alteration (in terms of benefit or impairment) of renal function during and after treatment with AAD in the context of the currently recommended treatment of chronic hepatitis C. Change in renal function was defined as the change in glomerular filtration (established by the CDK-EPI equation) greater than = 10 mL / min / 1.73 m2 or a change> 10% with respect to baseline glomerular filtration.;Secondary Objective: 1. Describe the proportion of patients with changes in renal function during and after completion of treatment with direct antivirals. 2. Evaluate changes in the tubular function of patients undergoing antiviral treatment. Change in tubular function is defined as the appearance of proteinuria or hematuria at any time during treatment administration. 3. Determine differences in acute renal failure and tubular damage between different treatments with rapid-acting antiviral agents. 4. Analyze if these alterations are maintained after the end of treatment and there is a tubular damage and renal function maintained over time. 5. Analyze the temporal profile of the alteration of the renal function and the reversibility of the same. 6. Describe the proportion of patients with glomerular filtration below 90 ml / min 7. Describe the proportion of patients with de novo tubular and glomerular alteration.;Primary end point(s): Glomerular filtration according to CKD-EPI;Timepoint(s) of evaluation of this end point: Basal, end of treatment and 12 weeks posttreatment	—

Measure

Time frame

Main Objective: To describe the potential alteration (in terms of benefit or impairment) of renal function during and after treatment with AAD in the context of the currently recommended treatment of chronic hepatitis C. Change in renal function was defined as the change in glomerular filtration (established by the CDK-EPI equation) greater than = 10 mL / min / 1.73 m2 or a change> 10% with respect to baseline glomerular filtration.;Secondary Objective: 1. Describe the proportion of patients with changes in renal function during and after completion of treatment with direct antivirals. 2. Evaluate changes in the tubular function of patients undergoing antiviral treatment. Change in tubular function is defined as the appearance of proteinuria or hematuria at any time during treatment administration. 3. Determine differences in acute renal failure and tubular damage between different treatments with rapid-acting antiviral agents. 4. Analyze if these alterations are maintained after the end of treatment and there is a tubular damage and renal function maintained over time. 5. Analyze the temporal profile of the alteration of the renal function and the reversibility of the same. 6. Describe the proportion of patients with glomerular filtration below 90 ml / min 7. Describe the proportion of patients with de novo tubular and glomerular alteration.;Primary end point(s): Glomerular filtration according to CKD-EPI;Timepoint(s) of evaluation of this end point: Basal, end of treatment and 12 weeks posttreatment

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Secondary

Measure	Time frame
Secondary end point(s): 1211/5000 Monitoring the reversibility of renal damage • creatinine clearance • Glomerular filtration, • Total proteinuria, • Presence of hematuria, • Albumin / Creatinine ratio, • Proteinuria / creatinine ratio • ß2 microglobulin / creatinine ratio • Retinol binding protein • Phosphorus / creatinine ratio Monitoring of acute renal damage (kinetics) • Cystatin C • NGAL • KIM-1 Efficacy of treatment • Sustained viral response (SVR12): Undetectable HCV RNA (<50 IU / ml) 12 weeks after the end of treatment • Viral response at week 4 after completion of treatment • Viral response at the end of treatment, HCV RNA at the end of treatment. • Viral response at treatment week 4; Rapid virological response. Undetectable HCV RNA (<50 IU / ml) at 4 weeks of initiation of treatment Security • Physical examination: basic before and after the experiment. • Vital signs • Lab tests • Clinical safety assessment. Adverse Events: O Adverse effects (EA): listed by treatment, laboratory values, values ??outside the reference range and descriptive statistics. O Adverse effects of special interest: Nephrotoxicity;Timepoint(s) of evaluation of this end point: Basal, weeks 2, 4, 8, end of treatment and 12 and 24 weeks posttreatment	—

Measure

Time frame

Secondary end point(s): 1211/5000 Monitoring the reversibility of renal damage • creatinine clearance • Glomerular filtration, • Total proteinuria, • Presence of hematuria, • Albumin / Creatinine ratio, • Proteinuria / creatinine ratio • ß2 microglobulin / creatinine ratio • Retinol binding protein • Phosphorus / creatinine ratio Monitoring of acute renal damage (kinetics) • Cystatin C • NGAL • KIM-1 Efficacy of treatment • Sustained viral response (SVR12): Undetectable HCV RNA (<50 IU / ml) 12 weeks after the end of treatment • Viral response at week 4 after completion of treatment • Viral response at the end of treatment, HCV RNA at the end of treatment. • Viral response at treatment week 4; Rapid virological response. Undetectable HCV RNA (<50 IU / ml) at 4 weeks of initiation of treatment Security • Physical examination: basic before and after the experiment. • Vital signs • Lab tests • Clinical safety assessment. Adverse Events: O Adverse effects (EA): listed by treatment, laboratory values, values ??outside the reference range and descriptive statistics. O Adverse effects of special interest: Nephrotoxicity;Timepoint(s) of evaluation of this end point: Basal, weeks 2, 4, 8, end of treatment and 12 and 24 weeks posttreatment

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Countries

Spain

Contacts

Public ContactBelen Ruiz-Antorán

Jose Luis Calleja Panero

34911917479

Outcome results

None listed

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