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

Early Phase 1
Completed
Conditions
Polycystic Kidney Diseases
Interventions
Registration Number
NCT03423810
Lead Sponsor
University of Kansas Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
14
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Group 1: HydralazineHydralazineParticipants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.
Primary Outcome Measures
NameTimeMethod
Change in mucin-like protocadherin (MUPCDH)Change from Baseline to Week 8
Change in polycystin-1 (PC1)Change from Baseline to Week 8
Secondary Outcome Measures
NameTimeMethod
Circulating methylated RASAL1 levelsChange from Baseline to Week 8

Trial Locations

Locations (1)

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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