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

NCT ID: NCT03423810

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2020-01-30

Brief Summary

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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

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Conditions

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Polycystic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1: Hydralazine

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

Group Type EXPERIMENTAL

Hydralazine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerri McGreal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR002366

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00141337

Identifier Type: -

Identifier Source: org_study_id

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