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Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tetracosactin
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring Autosomal dominant polycystic kidney disease, Adrenal functions, Renal volume, Glomerular filtration rate, Adrenal Cortex Function Tests

Eligibility Criteria

20 Years - 56 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects
  • Diagnosis of autosomal dominant polycystic kidney disease

Exclusion Criteria:

  • A glomerular filtration rate below 60 ml/min
  • History of recent major surgery
  • Systemic infections with fever
  • Significant hirsutism (Ferriman Gallwey score≥8)
  • Congenital adrenal hyperplasia
  • Late onset congenital adrenal hyperplasia
  • Systemic corticosteroid use (including previous use)
  • Topical corticosteroid use
  • Menstrual irregularity
  • History of thromboembolism
  • Uncontrolled diabetes or hypertension
  • History of psychosis
  • Pregnancy
  • Lactation
  • History of hypersensitivity to tetracosactin

Sites / Locations

  • Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Patients with autosomal dominant polycystic kidney disease

Healthy subjects

Outcomes

Primary Outcome Measures

Inadequate response to tetracosactin infusion

Secondary Outcome Measures

Full Information

First Posted
December 31, 2007
Last Updated
February 17, 2009
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT00598377
Brief Title
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Official Title
Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were enrolled.
Detailed Description
CONTEXT: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and extrarenal manifestations may be observed in many organ systems. Hypothalamus-pituitary-adrenal axis in patients with ADPKD was not evaluated extensively. OBJECTIVE: We aimed to evaluate the hypothalamus-pituitary-adrenal axis in ADPKD patients. METHODS: Twenty two ADPKD patients and 27 healthy subjects were enrolled. Basal dehydroepiandrosterone-sulfate (DHEAS) levels and cortisol and dehydroepiandrosterone responses to low dose short adrenocorticotropin stimulation test were assessed. Correlation analyses of these parameters with glomerular filtration rates, renal volumes and pain characteristics in patients with ADPKD were done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
Keywords
Autosomal dominant polycystic kidney disease, Adrenal functions, Renal volume, Glomerular filtration rate, Adrenal Cortex Function Tests

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients with autosomal dominant polycystic kidney disease
Arm Title
2
Arm Type
Active Comparator
Arm Description
Healthy subjects
Intervention Type
Drug
Intervention Name(s)
Tetracosactin
Other Intervention Name(s)
Synacthen
Intervention Description
1 microgram tetracosactin, intravenous injection, once for the test
Primary Outcome Measure Information:
Title
Inadequate response to tetracosactin infusion
Time Frame
30 and 60 minutes after the drug is administered

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects Diagnosis of autosomal dominant polycystic kidney disease Exclusion Criteria: A glomerular filtration rate below 60 ml/min History of recent major surgery Systemic infections with fever Significant hirsutism (Ferriman Gallwey score≥8) Congenital adrenal hyperplasia Late onset congenital adrenal hyperplasia Systemic corticosteroid use (including previous use) Topical corticosteroid use Menstrual irregularity History of thromboembolism Uncontrolled diabetes or hypertension History of psychosis Pregnancy Lactation History of hypersensitivity to tetracosactin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tevfik Ecder, Professor
Organizational Affiliation
Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Tufan, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neşe Çolak, Professor
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bora Uslu, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kültigin Türkmen, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mükremin Uysal, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nilüfer Alpay, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rian Dişçi, Professor
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bledi Çerkezi, Fellow
Organizational Affiliation
Istanbul University Istanbul Medical Faculty Department of Radiology
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey

12. IPD Sharing Statement

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Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

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