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Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

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.
ClinicalTrials.gov Identifier: NCT03880682
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Safak Mirioglu, Istanbul University

Tracking Information
First Submitted Date March 17, 2019
First Posted Date March 19, 2019
Last Update Posted Date March 20, 2019
Actual Study Start Date November 1, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2019)
SVR12 [ Time Frame: 6 months ]
Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03880682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 17, 2019)
  • Stable Graft Function [ Time Frame: 6-12 months ]
    Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals.
  • Stable Serum Trough Levels of Immunosuppressive Agents [ Time Frame: 6 months ]
    Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients
Official Title Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients
Brief Summary Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.
Condition
  • Kidney Transplant; Complications
  • Hepatitis C, Chronic
Intervention Not Provided
Study Groups/Cohorts Study Group
Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.
Publications * Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourlière M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 17, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Being a kidney transplant recipient.
  • Having a detectable level of HCV RNA.
  • Having direct acting antivirals for 12 or 24 weeks.

Exclusion Criteria:

  • Withdrawing or not providing consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03880682
Other Study ID Numbers 2018/1511
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Safak Mirioglu, Istanbul University
Study Sponsor Istanbul University
Collaborators Not Provided
Investigators
Principal Investigator: Safak Mirioglu, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Study Chair: Halil Yazici, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Study Chair: Sabahattin Kaymakoglu, MD Department of Internal Medicine, Istanbul Faculty of Medicine
PRS Account Istanbul University
Verification Date March 2019