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

Early Phase 1CompletedNCT03423810

University of Kansas Medical Center14 enrolled

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

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Polycystic Kidney Diseases

Interventions

HydralazineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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 Outcomes

Circulating methylated RASAL1 levels

Time frame: Change from Baseline to Week 8

Data from ClinicalTrials.gov

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