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Virus Therapy
Hepatitis C Positive Kidney Transplants for Kidney Failure
N/A
Waitlist Available
Led By Michael E de Vera, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active on the waiting list for kidney transplantation
Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of transplant through the last day of 12 month post transplant
Awards & highlights
Study Summary
This trial is testing whether it's safe and effective to transplant kidneys from people with hepatitis C into people without the virus.
Who is the study for?
This trial is for adults on the kidney transplant waiting list who don't have Hepatitis C. They can receive a kidney from donors who were positive for HCV, including those previously treated for HCV with undetectable viral load. Participants must be able to consent and speak English or Spanish. Those with HIV, pregnant or breastfeeding women, and individuals allergic to certain antiviral drugs are excluded.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of transplanting kidneys from donors with Hepatitis C into patients without the virus who need a kidney transplant. The goal is to see if this approach works well and doesn't cause harm.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with kidney transplantation as well as any complications arising from receiving an organ infected with Hepatitis C, although specific side effects aren't listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on the waiting list for a kidney transplant.
Select...
The donor organ I received tested positive for HCV.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of transplant through the last day of 12 month post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of transplant through the last day of 12 month post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year graft and patient survival
Side effects data
From 2014 Phase 2 trial • 5 Patients • NCT00801632100%
Engraftment syndrome
80%
Proteinuria
60%
Thrombocytopenia
60%
Urinary tract infection
40%
Transplant rejection
40%
Alanine aminotransferase increased
40%
Weight increased
40%
Hypophosphataemia
40%
Anaemia
40%
Clostridium difficile colitis
20%
Stomatitis
20%
Gastroenteritis
20%
Viral infection
20%
Post procedural haemorrhage
20%
Blood creatinine increased
20%
Pulmonary embolism
20%
Haematoma
20%
Thrombosis
20%
Neutropenia
20%
Diarrhoea
20%
Gastritis
20%
Nausea
20%
Drug toxicity
20%
Limb injury
20%
Hyperglycaemia
20%
Hyperkalaemia
20%
Hyponatraemia
20%
Atrial fibrillation
20%
Renal failure acute
20%
Vomiting
20%
Catheter related complication
20%
Pyrexia
20%
Catheter site infection
20%
Thrombotic microangiopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI-507
Trial Design
1Treatment groups
Experimental Treatment
Group I: Recipient of HCV positive kidney graftExperimental Treatment1 Intervention
A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kidney Transplantation
2008
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,957 Total Patients Enrolled
Michael E de Vera, MDPrincipal InvestigatorLoma Linda University Health
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or very sensitive to DAA or RBV.I am either male or female.I am on the waiting list for a kidney transplant.The donor organ I received tested positive for HCV.You have HIV along with the condition being studied.I speak English or Spanish.My donor was treated with an NS5a regimen.I do not have hepatitis C, or it was successfully treated.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Recipient of HCV positive kidney graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently able to join this research endeavor?
"As indicated on clinicaltrials.gov, the subject trial is no longer recruiting patients; it was initially posted on May 6th 2020 and last edited November 9th 2021. However, there are 177 other studies currently seeking enrolment of participants."
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