NCT00598377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

December 31, 2007

Last Update Submit

February 17, 2009

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal dominant polycystic kidney diseaseAdrenal functionsRenal volumeGlomerular filtration rateAdrenal Cortex Function Tests

Outcome Measures

Primary Outcomes (1)

  • Inadequate response to tetracosactin infusion

    30 and 60 minutes after the drug is administered

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with autosomal dominant polycystic kidney disease

Drug: Tetracosactin

2

ACTIVE COMPARATOR

Healthy subjects

Drug: Tetracosactin

Interventions

TetracosactinDRUG

1 microgram tetracosactin, intravenous injection, once for the test

Also known as: Synacthen
12

Eligibility Criteria

Age20 Years - 56 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Diagnosis of autosomal dominant polycystic kidney disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine

Istanbul, 34390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Cosyntropinadrenocorticotropin zinc

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Adrenocorticotropic HormoneMelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Tevfik Ecder, Professor

    Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • 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 CHAIR

  • Rian Dişçi, Professor

    Istanbul University Istanbul Medical Faculty Department of Public Health

    STUDY DIRECTOR

  • Bledi Çerkezi, Fellow

    Istanbul University Istanbul Medical Faculty Department of Radiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 21, 2008

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 19, 2009

Record last verified: 2008-02

Locations

TU(1)