The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease (POVA)
Primary Purpose
Polycystic Kidney, Autosomal Dominant, Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fluid intake
Thirsting
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Kidney, Autosomal Dominant focused on measuring CYSTS, KIDNEYS
Eligibility 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
Sites / Locations
- Department of Medical Research, Regional Hospital Holstebro
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Urine dilution test
Urine concentration test
Arm Description
Urine dilution test
Urine concentration test
Outcomes
Primary Outcome Measures
free water clearance CH20 u-osm
free water clearance (CH2O)
u-osm
urine osmolality
Secondary Outcome Measures
free water clearance
free water clearance (CH2O)
Full Information
NCT ID
NCT04363554
First Posted
April 23, 2020
Last Updated
April 28, 2020
Sponsor
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT04363554
Brief Title
The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease
Acronym
POVA
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney, Autosomal Dominant, Chronic Kidney Diseases
Keywords
CYSTS, KIDNEYS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A case control, randomized crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urine dilution test
Arm Type
Other
Arm Description
Urine dilution test
Arm Title
Urine concentration test
Arm Type
Other
Arm Description
Urine concentration test
Intervention Type
Other
Intervention Name(s)
Fluid intake
Intervention Description
The participants will intake fluid
Intervention Type
Other
Intervention Name(s)
Thirsting
Intervention Description
The participants will thirst
Primary Outcome Measure Information:
Title
free water clearance CH20 u-osm
Description
free water clearance (CH2O)
Time Frame
5 hours
Title
u-osm
Description
urine osmolality
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
free water clearance
Description
free water clearance (CH2O)
Time Frame
5 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
My Malmberg, MD
Organizational Affiliation
Departments of medical research and medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Research, Regional Hospital Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32867720
Citation
Malmberg MH, Mose FH, Pedersen EB, Bech JN. Urine concentration ability is reduced to the same degree in adult dominant polycystic kidney disease compared with other chronic kidney diseases in the same CKD-stage and lower THAN in healthy control subjects - a CASE control study. BMC Nephrol. 2020 Aug 31;21(1):379. doi: 10.1186/s12882-020-02043-w.
Results Reference
derived
Learn more about this trial
The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease
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