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


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


  • 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

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