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Trial record 75 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Effect of Harvoni on Proteinuria and Estimated Glomerular Filtration Rate (eGFR) in Hepatitis C (HCV) Associated Chronic Kidney Disease (CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02503735
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : September 9, 2019
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

Brief Summary:
Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD) who are treated with Harvoni for 12 weeks have improvements in their kidney disease.

Condition or disease Intervention/treatment Phase
Hepatitis C Chronic Kidney Disease Drug: Sofosbuvir/Ledipasvir FDC Not Applicable

Detailed Description:
The investigators hypothesize that patients with early stage (1-3) CKD caused by HCV infection will have significantly improved proteinuria and eGFR after viral eradication with 12 weeks of treatment Harvoni (LDV/SOF). This trial data will serve as the basis to support further study of LDV/SOF in patients with early CKD. Slowing progression of CKD is a critical goal, as the increasing incidence and prevalence of advanced CKD and ESRD (end stage renal disease) places significant health burden on patients and tremendous costs on our health-care system.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ledipasvir and Sofosbuvir on Proteinuria and Estimated Glomerular Filtration Rate in Patients With Early Stage (1-3) Hepatitis C Associated Chronic Kidney Disease
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg) Drug: Sofosbuvir/Ledipasvir FDC
12 weeks treatment with Harvoni
Other Name: Harvoni

Primary Outcome Measures :
  1. The percent change in proteinuria [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Mean change in eGFR as measured by creatinine and cystatin C-based estimating equation [ Time Frame: 24 weeks ]
  2. The proportion of patients achieving at least a 25% reduction in proteinuria [ Time Frame: 24 weeks ]
  3. Mean time in weeks to maximum reduction in proteinuria [ Time Frame: 24 weeks ]
  4. Mean change in renal function (creatine based eGFR) over 52 weeks [ Time Frame: 52 weeks ]
  5. Change in urinary β-2microglobulin levels before therapy with ledipasvir/sofosbuvir fixed dose combination pill [ Time Frame: 24 weeks ]
  6. Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject has signed the written informed consent
  • Male or female ≥ 18 year of age
  • HCV genotype 1 or 4 with ribonucleic acid (HCV RNA) greater than 1000 international units (IU)/milliliter (mL), determined by HCV RNA polymerase chain reaction Roche TaqMan quantitative assay.
  • Initial diagnosis of proteinuric chronic kidney disease occurred < 7 years prior to completion of screening
  • Women of childbearing potential (i.e. women who have not undergone hysterectomy or bilateral oophorectomy, or no medically documented ovarian failure, and are ≤ 50 years of age) must agree to 1 medically approved contraceptive measures and have their partners agree to an additional barrier method of contraception for the duration of the study and for 4 weeks after the last administration of the study drug. Women of childbearing potential must not rely on hormone-containing contraceptive as a form of birth control during the study but may use. An intrauterine device, female barrier methods with cervical cap or diaphragm with spermicidal agent, tubal sterilization, or vasectomy in male partners.
  • Male subjects must agree to consistently and correctly use a condom during heterosexual intercourse and avoid sperm donation for the duration of this study and for 90 days after the last dose of ledipasvir and sofosbuvir. Additionally, if their female partner is of childbearing potential (as defined above), their partner must agree to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive for 90 days after last study drug date. Hormone-containing contraceptive options for partners include implants of levonorgestrel, injectable progesterone, oral contraceptives, contraceptive vaginal ring, or transdermal contraceptive pat
  • Adequate organ function defined as follows platelets ≥ 50 x 109/L; hemoglobin ≥ 9 g/dL, estimated glomerular filtration rate ≥ 30mL/min/1.73m2 as estimated by CKD-Epi equation.
  • Liver imaging to exclude hepatocellular carcinoma (HCC) is required within 6 months in any patient with cirrhosis.
  • Has > 300mg/g creatinine proteinuria on two urine samples obtained within 30 days of starting ledipasvir and sofosbuvir.

Exclusion Criteria:

  • History of evidence of clinically significant disorder other than hepatitis C virus infection or clinically significant laboratory finding that in the investigator's judgment would pose a risk to subject safety, interfere with study procedures, or prevent completion of the study.
  • Pregnant or lactating female
  • Uncontrolled depression or psychiatric disease interfering with the ability to comply with the study procedures or complete the study
  • History or presence of any form of cancer within 3 years prior to enrollment, with the exception of excised basal cell or squamous cell carcinoma of the skin, stage 0 or 1 melanoma, or cervical carcinoma in site or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis.
  • Experience life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
  • Concomitant use of cimetidine, trimethoprim or other drugs which can increase tubular creatinine reabsorption
  • Uncontrolled cardiovascular or pulmonary disease
  • Uncontrolled hypertension
  • Known HIV infection
  • Known hypersensitivity to ledipasvir or sofosbuvir
  • Prior HCV treatment failure using a medication in the NS5A inhibitor class
  • Individuals who are taking the following medications and require continuation of the medications during the proposed study period will be excluded, given known interactions with ledipasvir-sofosbuvir: Carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, isoniazid, rifapentine, rosuvastatin, proton pump inhibitors, digoxin, modafinil, and St. John's wort, milk thistle, Echinacea.
  • Having an alternate explanation of chronic kidney disease, including:

    • Diabetic kidney disease, either by biopsy findings or duration of uncontrolled diabetes > 8 years without serologic evidence of immune-complex related kidney disease
    • Chronic hypertensive nephropathy without proteinuria
    • Lupus nephritis
    • Multiple myeloma
    • Obesity related proteinuria, BMI > 35
    • Ongoing nephrotoxic medication use, including NSAIDS
    • Polycystic kidney disease
    • Kidney biopsy showing an alternate explanation for chronic kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02503735

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Raymond Chung, Director of Hepatology, Massachusetts General Hospital Identifier: NCT02503735     History of Changes
Other Study ID Numbers: IN-US-337-1777
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by Raymond Chung, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Antiviral Agents
Anti-Infective Agents