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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00598377
Date of registration: 31/12/2007
Prospective Registration: No
Primary sponsor: Istanbul University
Public title: Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Scientific title: Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
Date of first enrolment: September 2006
Target sample size: 49
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00598377
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic  
Phase:  N/A
Countries of recruitment
Turkey
Contacts
Name:     Rian Disçi, Professor
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Public Health
Name:     Nese Çolak, Professor
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology
Name:     Bledi Çerkezi, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Radiology
Name:     Kültigin Türkmen, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Name:     Tevfik Ecder, Professor
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Affiliation:  Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology
Name:     Fatih Tufan, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Name:     Bora Uslu, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Name:     Mükremin Uysal, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Name:     Nilüfer Alpay, Fellow
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Affiliation:  Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 56 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Autosomal Dominant Polycystic Kidney Disease
Intervention(s)
Drug: Tetracosactin
Primary Outcome(s)
Inadequate response to tetracosactin infusion [Time Frame: 30 and 60 minutes after the drug is administered]
Secondary Outcome(s)
Secondary ID(s)
2007/233
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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