NCT07770984Not yet recruitingPhase 2/3
Treatment of CKD Patients With HCV
Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Tanta University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07770984
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 50
- From Sept 2026 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HCV-HIV co infection.
- HBV-HCV co infection.
Lab values
- 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.
Other
- Confirmed pregnancy.
- Unstable CKD patients.
- Patients who are recently stabilized on HD (less than 6 months).
- Patients on peritoneal dialysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.