NCT03801707

Brief Summary

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

January 9, 2019

Results QC Date

April 14, 2023

Last Update Submit

August 30, 2023

Conditions

Kidney TransplantHepatitis CHCV

Outcome Measures

Primary Outcomes (2)

  • Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment

    Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.

    12 weeks

  • Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies

    Elevation in liver enzyme \>5 times the upper limits, development of acute cholestatic hepatitis , or intolerance to Direct acting antiviral therapies was to test the safety of utilizing HepC positive kidneys for transplant.

    12 weeks

Secondary Outcomes (3)

  • Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant

    6 and 12 months

  • Patient's Survival at 6 and 12 Months

    6 and 12 months

  • Graft Survival at 6 and 12 Months

    12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.

Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]DRUG

fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C

Also known as: Epclusa
Intervention group
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]DRUG

Three tablets once a day for 12 weeks for treatment of hepatitis C

Also known as: Mavyret
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Adult age \>18 years able to provide consent
  • Lack of available living donor
  • Calculated pre-transplant reactive panel (cPRA) of \<80%
  • Estimated post-transplant survival (EPTS) index \>20% and \<80%
  • Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
  • No clinically significant pre-transplant liver disease
  • Living donor available
  • Dialysis time \>5 years
  • Listing for multi-organ transplantation
  • Active or recent history (\<6 months) of alcohol abuse or substance abuse
  • Clinically significant liver disease as determined by principal investigator
  • History of hepatocarcinoma
  • Pregnancy or lactation
  • Refusal to accept blood transfusion
  • HIV infection
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brenda Cuson

Columbus, Ohio, 43210, United States

Location

Related Publications (9)

  • Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, Wainright JL, Haynes CR, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2016 Annual Data Report: Kidney. Am J Transplant. 2018 Jan;18 Suppl 1(Suppl 1):18-113. doi: 10.1111/ajt.14557.

    PMID: 29292608BACKGROUND

  • Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16.

    PMID: 26569658BACKGROUND

  • Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.

    PMID: 26571066BACKGROUND

  • Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.

    PMID: 26476290BACKGROUND

  • Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.

    PMID: 26575258BACKGROUND

  • Younossi ZM, Stepanova M, Sulkowski M, Foster GR, Reau N, Mangia A, Patel K, Brau N, Roberts SK, Afdhal N, Nader F, Henry L, Hunt S. Ribavirin-Free Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -3 Clinical Trials. Clin Infect Dis. 2016 Oct 15;63(8):1042-1048. doi: 10.1093/cid/ciw496. Epub 2016 Jul 20.

    PMID: 27444413BACKGROUND

  • Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.

    PMID: 29886154BACKGROUND

  • Reau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X. Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Hepatology. 2018 Oct;68(4):1298-1307. doi: 10.1002/hep.30046. Epub 2018 Jul 25.

    PMID: 29672891BACKGROUND

  • 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: 29507971BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvirvelpatasvirsofosbuvir-velpatasvir drug combinationglecaprevirpibrentasvirglecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Results Point of Contact

Title
Brenda Cuson
Organization
The Ohio State University
Brenda.Cuson@osumc.edu
614-293-6883

Study Officials

  • Reem Daloul, MD

    Ohio State University School of Biomedical Science: The Ohio State University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine, Transplant Nephrology

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

March 22, 2019

Primary Completion

April 28, 2021

Study Completion

April 30, 2021

Last Updated

September 13, 2023

Results First Posted

September 13, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)