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

University of Kansas

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Kidney Diseases

Treatments: Drug: Hydralazine

Study type: Interventional

Funder types: Other

Identifiers

NCT03423810

STUDY00141337

UL1TR002366 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Group 1: Hydralazine

Experimental group

Description:

Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.

Treatment:

Drug: Hydralazine