NCT03423810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

January 31, 2018

Last Update Submit

February 25, 2020

Conditions

Polycystic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

  • Change in polycystin-1 (PC1)

    Change from Baseline to Week 8

  • Change in mucin-like protocadherin (MUPCDH)

    Change from Baseline to Week 8

Secondary Outcomes (1)

  • Circulating methylated RASAL1 levels

    Change from Baseline to Week 8

Study Arms (1)

Group 1: Hydralazine

EXPERIMENTAL

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

Drug: Hydralazine

Interventions

HydralazineDRUG

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.

Group 1: Hydralazine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of ADPKD
  • estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m\^2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases

Interventions

Hydralazine

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

PhthalazinesPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kerri McGreal, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 6, 2018

Study Start

April 23, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

US(1)