Treatment of CKD Patients With HCV

Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07770984
Lead Sponsor: Tanta UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Phase 2Phase 3
Enrollment: 50Estimated
Last Update Posted: Aug 20, 2026Actual
Start Date: Sep 15, 2026Estimated
Primary Completion Date: Nov 15, 2026Estimated
Completion Date: May 15, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV
Brief Summary: The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are:

outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels.

outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment.

If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health.

Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.

Conditions

The medical conditions and diseases this study investigates.

HCV Infection ( Genotype 4) in CKD Patients

Interventions

The treatments and procedures being evaluated in this study.

SOF+DCV
OBV/PTV/r) ± ribavirin (RBV)

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Both male and female.

Adults more than 18 years.

Patients with CKD different stages stable on treatment with or without HD.

HD Patients should be stable for at least 6 months under regular hemodialysis.

Clinically stable condition as outpatients.

Patients with HCV infections (serum positive for HCV GT4 with HCV RNA>1000 IU/ml by PCR).

White blood cells count more than 2500/mm3.

Platelet count more than 7500/mm3.

Exclusion Criteria:

Confirmed pregnancy.

HCV-HIV co infection.

HBV-HCV co infection.

Unstable CKD patients.

Patients who are recently stabilized on HD (less than 6 months).

Patients on peritoneal dialysis.

For patients without cirrhosis, Patients will be excluded if ALT or AST more than five times the upper limit of normal.

For patients with cirrhosis, Patients will be excluded if ALT or AST are higher than seven times the upper limit of normal.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Ahmed El Gammalh, Bsc in pharmaceutical sciencesContact

dr_ahmed_k658@yahoo.com+201128907433

Locations

Where the study is run and whether each site is currently recruiting.

Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee

Tanta, Gharbia Governorate 31719, Egypt

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Tanta UniversityOTHER

Similar Studies

Other registered studies that closely resemble this one.

Detailed Description

The study will be conducted on HCV patients with CKD in Tanta University Hospitals (Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee). The duration of the study will be at least 6 months for treatment and follow up.

A total number of fifty (50) chronic renal disease patients with HCV infection to be treated with the DAAs will be selected to be adjusted for age, sex, comorbid conditions, serum albumin, phosphorus and creatinine clearance and divided in two groups.

Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks. Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.

Blood samples will be collected at enrollment and periodically to evaluate the serum levels of:

Liver Function Tests: • ALT, AST, Serum Albumin & Serum Bilirubin.
Kidney Function Tests: • Serum Creatinine & Urea
Serum Electrolytes: • Serum Calcium, Serum Potassium & Serum Phosphorus.
HCV RNA quantitative PCR.
AFP for Cirrhotic Patients.
INR.
Parathormone (PTH) for HD Patients.
Blood Sugar for Diabetic Patients
CBC. Health-related quality of life measures will be assessed using KDQOL 36 survey.

Study design:

This clinical study is non randomized, interventional, prospective and open label study groups.
HCV status will be determined based on an established diagnosis of HCV infection or positive HCV serology at study enrollment.
Group 1: 25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive Sofosbuvir 400mg/day and Daclatasvir 60mg/day for 12 weeks.
Group 2: 25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg (2 Tablets Qurevo®/day) and Ribavirin 200mg for 12 weeks.
Qurevo® will be given for Group B (on the day of dialysis, it will be given after dialysis session for the HD patients).
Ribavirin will be given for Group B (on the day of dialysis, it will be given 4 hrs. before dialysis session for the HD patients).
Health-related quality of life measures will be assessed using specific survey.