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Trial record 1 of 1 for:    NCT04363554
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The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease (POVA)

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ClinicalTrials.gov Identifier: NCT04363554
Recruitment Status : Completed
First Posted : April 27, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jesper Norgaard Bech, Regional Hospital Holstebro

Brief Summary:
The ability to concentrate and dilute urine is primarily regulated via vasopressin (AVP) dependent Aquaporin-2 water channels (AQP2 channels) in the kidney's collecting duct. Autosomal dominant polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cyst in the kidneys, causing gradual renal function-loss. Previous studies indicate that ADPKD patients have decreased urine concentration, higher plasma osmolality, and plasma AVP levels compared to healthy controls. Previous studies also indicate that ADPKD patients' dysregulated AVP is an important factor for the pathogenesis and progression of the disease. It is unclear whether ADPKD patients' ability to concentrate and dilute urine are different from those of other cause of chronic renal disease to the same degree. It is also unclear, what mechanisms cause the decreased ability to concentrate and dilute urine in chronic renal disease patients. The purpose of this trial is to investigate the difference in renal function during concentration and dilution test in a case-control, randomized, cross-examination study with ADKPD patients or other cause of chronic renal disease compared to healthy volunteers.

Condition or disease Intervention/treatment Phase
Polycystic Kidney, Autosomal Dominant Chronic Kidney Diseases Other: Fluid intake Other: Thirsting Not Applicable

Detailed Description:
The aim is to measure the difference in renal function, including kidney tubular function, blood pressure and vasoactive hormones in patients with Autosomal dominant polycystic kidney disease (ADPKD) or other chronic renal disease compared to healthy volunteers, during concentration and dilution test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A case control, randomized crossover study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) or Other Cause of Chronic Renal Disease Compared to Healthy Volunteers
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : April 20, 2020


Arm Intervention/treatment
Urine dilution test
Urine dilution test
Other: Fluid intake
The participants will intake fluid

Urine concentration test
Urine concentration test
Other: Thirsting
The participants will thirst




Primary Outcome Measures :
  1. free water clearance CH20 u-osm [ Time Frame: 5 hours ]
    free water clearance (CH2O)

  2. u-osm [ Time Frame: 4 hours ]
    urine osmolality


Secondary Outcome Measures :
  1. free water clearance [ Time Frame: 5 hours ]
    free water clearance (CH2O)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ADPKD patients: -age >18 years, diagnosis with ADPKD, informed consent, contraception for fertile women
  • Patients with chronic kidney disease: age >18 years, diagnosis with chronic kidney disease other then ADPKD, informed consent, contraception for fertile women
  • Healthy volunteers: age >18 years, healthy, informed consent, contraception for fertile women

Exclusion Criteria:

  • ADPKD patients: Renal transplantation, operation in the kidney, Diabetes mellitus, neoplastic conditions, pregnancy, breastfeeding, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.
  • Patients with chronic kidney disease: Renal transplantation, operation in the kidney, Diabetes mellitus, medullary cystic kidney disease, lithium nephropathy, neoplastic conditions, pregnancy, nursing, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.
  • Healthy volunteers: Arterial hypertension, significant clinical signs of heart, lungs, liver, kidneys, endocrine, brain or neoplastic disorders, alcohol or drug abuse, medical treatment, smoking, pregnancy or breastfeeding, smoking, clinically significant abnormal findings in blood, urine tests or electrocardiogram, blood donation within the last month before the examination date in the first trial sequence, intolerance to or unacceptable side effects of urine concentration and urine dilution test

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): NCT04363554


Locations
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Denmark
Department of Medical Research, Regional Hospital Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
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Principal Investigator: My Malmberg, MD Departments of medical research and medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jesper Norgaard Bech, Head of University Clinic in Nephrology and Hypertension, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT04363554    
Other Study ID Numbers: My-1-2017
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesper Norgaard Bech, Regional Hospital Holstebro:
CYSTS
KIDNEYS
Additional relevant MeSH terms:
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Arthrogryposis
Kidney Diseases
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn