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

February 25, 2020 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Hydralazine
Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Circulating methylated RASAL1 levels
Time Frame: Change from Baseline to Week 8
Change from Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Kerri McGreal, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2018

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (ACTUAL)

February 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00141337
  • UL1TR002366 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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