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

Primary Purpose

Polycystic Kidney Diseases

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hydralazine

About this trial

This is an interventional basic science trial for Polycystic Kidney Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1: Hydralazine

Arm Description

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

Outcomes

Primary Outcome Measures

Change in polycystin-1 (PC1)

Change in mucin-like protocadherin (MUPCDH)

Secondary Outcome Measures

Circulating methylated RASAL1 levels

Full Information

NCT ID

NCT03423810

First Posted

January 31, 2018

Last Updated

February 25, 2020

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03423810

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

April 23, 2018 (Actual)

Primary Completion Date

January 30, 2020 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Kidney Diseases

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Hydralazine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hydralazine

Intervention Description

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 Outcome Measure Information:

Title

Change in polycystin-1 (PC1)

Time Frame

Change from Baseline to Week 8

Title

Change in mucin-like protocadherin (MUPCDH)

Time Frame

Change from Baseline to Week 8

Secondary Outcome Measure Information:

Title

Circulating methylated RASAL1 levels

Time Frame

Change from Baseline to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerri McGreal, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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