Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients

Overview

The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2020

Interventions

  • Drug: Hydralazine
    • Participants will be asked to take pills two times per day for 6 weeks. This is a dose increasing study with potential doses ranging from 5 mg two times per day to 50 mg two times per day.

Arms, Groups and Cohorts

  • Experimental: Group 1: Hydralazine
    • Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in polycystin-1 (PC1)
    • Time Frame: Change from Baseline to Week 8
  • Change in mucin-like protocadherin (MUPCDH)
    • Time Frame: Change from Baseline to Week 8

Secondary Measures

  • Circulating methylated RASAL1 levels
    • Time Frame: Change from Baseline to Week 8

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed diagnosis of ADPKD – estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m^2 Exclusion Criteria:

  • History of systemic lupus erythematous or other rheumatologic disorder – Baseline anti-nuclear antibody (ANA) >1:80 for females and >1:40 for males – Blood pressure < 120/80 without anti-hypertensive – Angina pectoris or myocardial infarction in the last 6 months – Liver disease – Allergy to hydralazine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kerri McGreal, MD, Principal Investigator, University of Kansas Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.