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The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT ID: NCT04363554

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2020-04-20

Brief Summary

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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

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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.

Conditions

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Polycystic Kidney, Autosomal Dominant Chronic Kidney Diseases

Keywords

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CYSTS KIDNEYS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A case control, randomized crossover study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Urine dilution test

Urine dilution test

Group Type OTHER

Fluid intake

Intervention Type OTHER

The participants will intake fluid

Urine concentration test

Urine concentration test

Group Type OTHER

Thirsting

Intervention Type OTHER

The participants will thirst

Interventions

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Fluid intake

The participants will intake fluid

Intervention Type OTHER

Thirsting

The participants will thirst

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Jesper Norgaard Bech

Head of University Clinic in Nephrology and Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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My Malmberg, MD

Role: PRINCIPAL_INVESTIGATOR

Departments of medical research and medicine

Locations

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Department of Medical Research, Regional Hospital Holstebro

Holstebro, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 32867720 (View on PubMed)

Other Identifiers

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My-1-2017

Identifier Type: -

Identifier Source: org_study_id