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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03423810

Enrollment

Registered

2018-02-06

Start date

2018-04-23

Completion date

2020-01-30

Last updated

2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Kidney Diseases

Brief summary

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.

Interventions

DRUGHydralazine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in polycystin-1 (PC1)	Change from Baseline to Week 8
Change in mucin-like protocadherin (MUPCDH)	Change from Baseline to Week 8

Secondary

Measure	Time frame
Circulating methylated RASAL1 levels	Change from Baseline to Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026