Autosomal Dominant Polycystic Kidney DiseaseNCT00598377
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
A study testing Tetracosactin in people with Autosomal Dominant Polycystic Kidney Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- Tetracosactin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Diagnosis of autosomal dominant polycystic kidney disease
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine
Istanbul, 34390
About this study
Official title: Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
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.
Read the 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.
- Being tested
- Tetracosactin
- Keywords
- Autosomal dominant polycystic kidney disease, Adrenal functions, Renal volume, Glomerular filtration rate, Adrenal Cortex Function Tests
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracosactinDrug
Also called Synacthen
1 microgram tetracosactin, intravenous injection, once for the test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients with autosomal dominant polycystic kidney disease Receives: Drug: Tetracosactin |
| 2 | Active comparator | Healthy subjects Receives: Drug: Tetracosactin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate response to tetracosactin infusion
Measured: 30 and 60 minutes after the drug is administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Tevfik Ecder, Professor, Principal investigator, Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of NephrologyFatih Tufan, Fellow, Study director, Istanbul University Istanbul Medical Faculty Department of Internal MedicineNeşe Çolak, Professor, Study director, Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of EndocrinologyBora Uslu, Fellow, Study chair, Istanbul University Istanbul Medical Faculty Department of Internal MedicineKültigin Türkmen, Fellow, Study chair, Istanbul University Istanbul Medical Faculty Department of Internal MedicineMükremin Uysal, Fellow, Study chair, Istanbul University Istanbul Medical Faculty Department of Internal MedicineNilüfer Alpay, Fellow, Study chair, Istanbul University Istanbul Medical Faculty Department of Internal MedicineRian Dişçi, Professor, Study director, Istanbul University Istanbul Medical Faculty Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598377
- Sponsor's protocol ID
- 2007/233
- Other IDs
- 2007/233
- Status last verified
- Feb 2008
- First submitted
- 31 Dec 2007
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT00598377
- Acronym / sponsor ID
- 2007/233
- Keywords
- Autosomal dominant polycystic kidney disease, Adrenal functions, Renal volume, Glomerular filtration rate, Adrenal Cortex Function Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TetracosactinPatients with autosomal dominant polycystic kidney disease |
| 2 | Active comparator | Drug: TetracosactinHealthy subjects |
Who may qualify
- Ages
- 20 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Diagnosis of autosomal dominant polycystic kidney disease
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetracosactinAlso: Synacthen1 microgram tetracosactin, intravenous injection, once for the test | Drug | 1, 2 |
Primary outcome
Inadequate response to tetracosactin infusion
Time frame: 30 and 60 minutes after the drug is administered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tevfik Ecder, Professor principal investigator
Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology
Fatih Tufan, Fellow study director
Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Neşe Çolak, Professor study director
Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetracosactin in people with Autosomal Dominant Polycystic Kidney Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inadequate response to tetracosactin infusion (time frame: 30 and 60 minutes after the drug is administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.