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| ID | Type | Description | Link |
|---|---|---|---|
| Merck MISP 54841 | Other Grant/Funding Number | Merck |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elbasvir/grazoprevir for HCV+ kidney transplant recipients | Experimental | Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) | Drug | Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Undetectable HCV RNA at SVR12 | Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV. | 12 weeks post-treatment (24 weeks post-transplant) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365 | Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365. | 1 year post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Chung, MD | Massachusetts General Hospital (Partners Healthcare) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20353475 | Background | Kucirka LM, Singer AL, Ros RL, Montgomery RA, Dagher NN, Segev DL. Underutilization of hepatitis C-positive kidneys for hepatitis C-positive recipients. Am J Transplant. 2010 May;10(5):1238-46. doi: 10.1111/j.1600-6143.2010.03091.x. Epub 2010 Mar 26. |
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Data will be shared with study sponsor and with the hopes of publication.
Protocol will be shared for up to 1 year after the final patient has dosed.
Protocol will only be shared with Institutional Review Board (IRB) approved study staff and PI approved collaborators.
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33 patients signed consent for the study. Of those, 23 patients were deemed "ready" for transplant and were put on the waitlist for a HCV kidney (10 patients did not meet the "readiness" criteria for kidney transplantation). Of those, 8 patients were transplanted with an HCV+ kidney.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients | Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients | Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Undetectable HCV RNA at SVR12 | Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV. | Posted | Count of Participants | Participants | 12 weeks post-treatment (24 weeks post-transplant) |
|
Adverse event data were collected from time of consent to 1 year post-transplant
Adverse event data collection is still ongoing for two participants who have yet to reach the one year-post transplant mark.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients | Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocele | Surgical and medical procedures | Non-systematic Assessment | Lymphocele post kidney transplant requiring drain placement, and subsequent laparoscopic fenestration of peri-nephric lymphocele (x2). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated alanine transaminase (ALT) | Hepatobiliary disorders | Non-systematic Assessment | ALT measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365 High ALT defined as being above 55 U/L for males and 33 U/L for females |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Chung | Massachusetts General Hospital | 617-724-7562 | Chung.Raymond@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Jan 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000589335 | elbasvir |
| C578009 | grazoprevir |
| C000611265 | elbasvir-grazoprevir drug combination |
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|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| End stage renal disease (ESRD) cause | Count of Participants | Participants |
|
| Blood type | Count of Participants | Participants |
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| Prior transplant | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| History of diabetes | Count of Participants | Participants |
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| Days on waitlist prior to consent | Median | Inter-Quartile Range | days |
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| Days from consent to transplant | Median | Inter-Quartile Range | days |
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| Length of hospital stay | Count of Participants | Participants |
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|
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| Secondary | Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365 | Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365. | Patients who received a HCV+ kidney transplant and were treated with elbasvir (50mg) / grazoprevir (100mg) for 12 weeks following transplant. | Posted | Number | participants | 1 year post transplant |
|
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| 4 |
| 8 |
|
| Renal vein thrombosis | Renal and urinary disorders | Non-systematic Assessment | Immediate graft failure due to renal vein thrombosis. Allograft explanted on post-operative day 1. Patient anticoagulated and returned to dialysis. Workup for coagulopathy demonstrated positive test for lupus anticoagulant. Achieved SVR12. |
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| Delayed graft function | Renal and urinary disorders | Non-systematic Assessment | Patient readmitted to hospital for one day for delayed graft function. Graft function improved and patient was discharged. |
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| Acute kidney injury (AKI) | Renal and urinary disorders | Non-systematic Assessment | Admitted to hospital for AKI. Discharged after one day upon improvement. |
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| Elevated aspartate transaminase (AST) | Hepatobiliary disorders | Non-systematic Assessment | AST measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365 High AST defined as being above 40 U/L for males and 32 U/L for females |
|
| Elevated total bilirubin | Hepatobiliary disorders | Non-systematic Assessment | Bilirubin measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365 High bilirubin defined as being above 1.0 mg/dL |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Patient who was admitted for AKI also had diarrhea during admission. Was discharged after 1 day upon improvement. |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Patient who was admitted for AKI also had abdominal pain during admission. Was discharged after 1 day upon improvement. |
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| Hematoma at surgical site | Surgical and medical procedures | Non-systematic Assessment | Patient who was admitted for AKI also had hematoma at surgical site during admission. Was discharged after 1 day upon improvement. |
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| Hypophosphatemia | Blood and lymphatic system disorders | Non-systematic Assessment | Patient who was admitted for AKI also had hypophosphatemia during admission. Was discharged after 1 day upon improvement. |
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| Hypomagnesemia | Blood and lymphatic system disorders | Non-systematic Assessment | Patient who was admitted for AKI also had hypomagnesemia during admission. Was discharged after 1 day upon improvement. |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|
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| Day 56 |
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| Day 84 |
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| Day 112 |
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| Day 168 |
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| Day 252 |
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| Day 365 |
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