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

Polycystic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423810
• Other study ID #: STUDY00141337
• Secondary ID: UL1TR002366
• Status: Completed
• Phase: Early Phase 1
• Start date: April 23, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Diseases

Intervention

Drug:
• Hydralazine
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in polycystin-1 (PC1)		Change from Baseline to Week 8
Primary	Change in mucin-like protocadherin (MUPCDH)		Change from Baseline to Week 8
Secondary	Circulating methylated RASAL1 levels		Change from Baseline to Week 8