## Protocol Section
### Identification Module
**NCT ID:** NCT04605679

**Brief Title:** Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

**Official Title:** Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients

#### Organization Study ID Info
**ID:** 5200098
#### Organization
**Class:** OTHER
**Full Name:** Loma Linda University
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-05

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-03

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-05-06

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2020-10-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-25
**Study First Submit QC Date:** 2020-10-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loma Linda University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

### Conditions Module

**Conditions:**

- Kidney Failure

**Keywords:**

- HCV

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Procedure: Kidney Transplantation

**Label:** Recipient of HCV positive kidney graft

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Recipient of HCV positive kidney graft

**Description:** A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

**Name:** Kidney Transplantation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Will track subjects post transplant for 12 months

**Measure:** 1-year graft and patient survival

**Time Frame:** From the date of transplant through the last day of 12 month post transplant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female
* Age 18 and older
* English and Spanish speaking patients
* Active on the waiting list for kidney transplantation
* Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to DAA or RBV
* Pregnancy and/or actively breastfeeding

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Loma Linda

**Country:** United States

**Facility:** Loma Linda University Health-Transplant Institute

**State:** California

**Zip:** 92354

#### Overall Officials

**Official 1:**

**Affiliation:** Loma Linda University Health

**Name:** Michael E de Vera, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Reese PP, Abt PL, Blumberg EA, Van Deerlin VM, Bloom RD, Potluri VS, Levine M, Porrett P, Sawinski D, Nazarian SM, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Gentile C, Smith J, Niknam BA, Bleicher M, Reddy KR, Goldberg DS. Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients: A Single-Group Trial. Ann Intern Med. 2018 Sep 4;169(5):273-281. doi: 10.7326/M18-0749. Epub 2018 Aug 7.

**PMID:** 30083748

**Citation:** Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.

**PMID:** 29507971

#### See Also Links

**Label:** Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients

**URL:** https://pubmed.ncbi.nlm.nih.gov/30083748

**Label:** Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients

**URL:** https://pubmed.ncbi.nlm.nih.gov/29507971

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: LOW

- As Found: Unknown

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Kidney Failure

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000051437

- Term: Renal Insufficiency

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
