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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

Must not have

Donor previously treated with an NS5a containing regimen (if treatment history of donor known)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of transplant through the last day of 12 month post transplant

Awards & highlights

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.

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.

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 below

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I am on the waiting list for a kidney transplant.

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The donor organ I received tested positive for HCV.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My donor was treated with an NS5a regimen.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of transplant through the last day of 12 month post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1-year graft and patient survival

Side effects data

From 2014 Phase 2 trial • 5 Patients • NCT00801632

100%

Engraftment syndrome

80%

Proteinuria

60%

Thrombocytopenia

60%

Urinary tract infection

40%

Anaemia

40%

Weight increased

40%

Transplant rejection

40%

Clostridium difficile colitis

40%

Alanine aminotransferase increased

40%

Hypophosphataemia

20%

Atrial fibrillation

20%

Stomatitis

20%

Neutropenia

20%

Vomiting

20%

Limb injury

20%

Thrombotic microangiopathy

20%

Gastroenteritis

20%

Gastritis

20%

Viral infection

20%

Catheter related complication

20%

Post procedural haemorrhage

20%

Diarrhoea

20%

Blood creatinine increased

20%

Nausea

20%

Pulmonary embolism

20%

Haematoma

20%

Thrombosis

20%

Pyrexia

20%

Drug toxicity

20%

Hyponatraemia

20%

Catheter site infection

20%

Hyperkalaemia

20%

Renal failure acute

20%

Hyperglycaemia

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met