Trial record 1 of 1 for:
NCT04363554
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 |
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Recruitment Status :
Completed
First Posted : April 27, 2020
Last Update Posted : April 30, 2020
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Sponsor:
Regional Hospital Holstebro
Information provided by (Responsible Party):
Jesper Norgaard Bech, Regional Hospital Holstebro
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Polycystic kidney disease
| Arm | Intervention/treatment |
|---|---|
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Urine dilution test
Urine dilution test
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Other: Fluid intake
The participants will intake fluid |
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Urine concentration test
Urine concentration test
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Other: Thirsting
The participants will thirst |
Primary Outcome Measures :
- free water clearance CH20 u-osm [ Time Frame: 5 hours ]free water clearance (CH2O)
- u-osm [ Time Frame: 4 hours ]urine osmolality
Secondary Outcome Measures :
- 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
| Denmark | |
| Department of Medical Research, Regional Hospital Holstebro | |
| Holstebro, Denmark, 7500 | |
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
| Principal Investigator: | My Malmberg, MD | Departments of medical research and medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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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 |