Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
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ClinicalTrials.gov Identifier: NCT00598377 |
Recruitment Status
:
Completed
First Posted
: January 21, 2008
Last Update Posted
: February 19, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autosomal Dominant Polycystic Kidney Disease | Drug: Tetracosactin | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Patients with autosomal dominant polycystic kidney disease
|
Drug: Tetracosactin
1 microgram tetracosactin, intravenous injection, once for the test
Other Name: Synacthen
|
Active Comparator: 2
Healthy subjects
|
Drug: Tetracosactin
1 microgram tetracosactin, intravenous injection, once for the test
Other Name: Synacthen
|
- Inadequate response to tetracosactin infusion [ Time Frame: 30 and 60 minutes after the drug is administered ]

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Ages Eligible for Study: | 20 Years to 56 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT00598377
Turkey | |
Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine | |
Istanbul, Turkey, 34390 |
Principal Investigator: | Tevfik Ecder, Professor | Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology | |
Study Director: | Fatih Tufan, Fellow | Istanbul University Istanbul Medical Faculty Department of Internal Medicine | |
Study Director: | Neşe Çolak, Professor | Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology | |
Study Chair: | Bora Uslu, Fellow | Istanbul University Istanbul Medical Faculty Department of Internal Medicine | |
Study Chair: | Kültigin Türkmen, Fellow | Istanbul University Istanbul Medical Faculty Department of Internal Medicine | |
Study Chair: | Mükremin Uysal, Fellow | Istanbul University Istanbul Medical Faculty Department of Internal Medicine | |
Study Chair: | Nilüfer Alpay, Fellow | Istanbul University Istanbul Medical Faculty Department of Internal Medicine | |
Study Director: | Rian Dişçi, Professor | Istanbul University Istanbul Medical Faculty Department of Public Health | |
Study Chair: | Bledi Çerkezi, Fellow | Istanbul University Istanbul Medical Faculty Department of Radiology |
Responsible Party: | Tevfik Ecder, Istanbul University, Istanbul Medical Faculty, Division of Nephrology |
ClinicalTrials.gov Identifier: | NCT00598377 History of Changes |
Other Study ID Numbers: |
2007/233 |
First Posted: | January 21, 2008 Key Record Dates |
Last Update Posted: | February 19, 2009 |
Last Verified: | February 2008 |
Keywords provided by Istanbul University:
Autosomal dominant polycystic kidney disease Adrenal functions Renal volume Glomerular filtration rate Adrenal Cortex Function Tests |
Additional relevant MeSH terms:
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Epinephrine Racepinephrine Epinephryl borate Cosyntropin Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |