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Completed

NCT Number: NCT03423810

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.

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Key information

Conditions

Polycystic Kidney Diseases Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydralazine

Drug

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.

Primary outcomes

  1. Change in polycystin-1 (PC1)

    Time frame: Change from Baseline to Week 8

  2. Change in mucin-like protocadherin (MUPCDH)

    Time frame: Change from Baseline to Week 8

Secondary outcomes

  1. Circulating methylated RASAL1 levels

    Time frame: Change from Baseline to Week 8

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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