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

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ClinicalTrials.gov Identifier: NCT03423810
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Polycystic Kidney Diseases Drug: Hydralazine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing a Dose‐Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




Primary Outcome Measures :
  1. Change in polycystin-1 (PC1) [ Time Frame: Change from Baseline to Week 8 ]
  2. Change in mucin-like protocadherin (MUPCDH) [ Time Frame: Change from Baseline to Week 8 ]

Secondary Outcome Measures :
  1. Circulating methylated RASAL1 levels [ Time Frame: Change from Baseline to Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423810


Contacts
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Contact: Debbie Griffin, RN 913-588-7691 dgriffin3@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Kerri McGreal, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03423810     History of Changes
Other Study ID Numbers: STUDY00141337
UL1TR002366 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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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

Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Kidney Diseases, Cystic
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Hydralazine
Antihypertensive Agents
Vasodilator Agents