NCT00478335

Brief Summary

The purpose of this research study is to determine if two investigational medications will be more effective in decreasing urine output than the currently available and routinely used medications in patients with congenital nephrogenic diabetes insipidus (NDI).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

5.4 years

First QC Date

May 23, 2007

Results QC Date

May 27, 2014

Last Update Submit

February 8, 2018

Conditions

Nephrogenic Diabetes Insipidus

Keywords

congenital nephrogenic diabetes insipiduspolyuriaurine osmolalityaquaporin-2vasopressin V2 receptor

Outcome Measures

Primary Outcomes (1)

  • 24h Urine Volume

    urine volume in mL/d

    4-days

Study Arms (2)

Active Therapy

EXPERIMENTAL

4-day treatment with hydrochlorothiazide/amiloride, indomethacin, calcitonin, sildenafil

Drug: sildenafilDrug: calcitoninDrug: hydrochlorothiazide/amilorideDrug: indomethacin

Placebo Control

PLACEBO COMPARATOR

4-day treatment with hydrochlorothiazide/amiloride, indomethacin, placebo for calcitonin, placebo for sildenafil

Drug: hydrochlorothiazide/amilorideDrug: indomethacinDrug: Placebo for sildenafilDrug: placebo for calcitonin

Interventions

sildenafilDRUG

25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight

Also known as: Viagra
Active Therapy
calcitoninDRUG

one nasal spray daily for 4 days

Also known as: Miacalcic
Active Therapy
hydrochlorothiazide/amilorideDRUG

25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight

Also known as: Moduret, Moduretic
Active TherapyPlacebo Control
indomethacinDRUG

50 mg QD or 50 mg BID x 8 days depending on subject weight

Also known as: Indocin
Active TherapyPlacebo Control
Placebo for sildenafilDRUG

one tablet daily for 4 days

Placebo Control
placebo for calcitoninDRUG

one nasal spray daily

Placebo Control

Eligibility Criteria

Age5 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Known diagnosis of Congenital Nephrogenic Diabetes Insipidus (CNDI)
  • Age 5 to 25 years
  • Normal kidney function
  • Post-void residual urine \< 200 ml (determined by bladder ultrasound)

You may not qualify if:

  • Impaired kidney function
  • Known urinary retention or bladder dysfunction
  • High blood pressure
  • Other significant chronic medical disease (e.g., heart failure, liver disease, etc.)
  • Allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

University of Aarhus

Aarhus, Denmark

Location

Related Publications (8)

  • Bichet DG. Nephrogenic diabetes insipidus. Adv Chronic Kidney Dis. 2006 Apr;13(2):96-104. doi: 10.1053/j.ackd.2006.01.006.

    PMID: 16580609BACKGROUND

  • Fujiwara TM, Bichet DG. Molecular biology of hereditary diabetes insipidus. J Am Soc Nephrol. 2005 Oct;16(10):2836-46. doi: 10.1681/ASN.2005040371. Epub 2005 Aug 10.

    PMID: 16093448BACKGROUND

  • Schrier RW, Cadnapaphornchai MA. Renal aquaporin water channels: from molecules to human disease. Prog Biophys Mol Biol. 2003 Feb;81(2):117-31. doi: 10.1016/s0079-6107(02)00049-4.

    PMID: 12565698BACKGROUND

  • Schrier RW, Cadnapaphornchai MA, Umenishi F. Water-losing and water-retaining states: role of water channels and vasopressin receptor antagonists. Heart Dis. 2001 May-Jun;3(3):210-4. doi: 10.1097/00132580-200105000-00014.

    PMID: 11975794BACKGROUND

  • Nielsen S, Kwon TH, Frokiaer J, Agre P. Regulation and dysregulation of aquaporins in water balance disorders. J Intern Med. 2007 Jan;261(1):53-64. doi: 10.1111/j.1365-2796.2006.01760.x.

    PMID: 17222168BACKGROUND

  • Kotnik P, Nielsen J, Kwon TH, Krzisnik C, Frokiaer J, Nielsen S. Altered expression of COX-1, COX-2, and mPGES in rats with nephrogenic and central diabetes insipidus. Am J Physiol Renal Physiol. 2005 May;288(5):F1053-68. doi: 10.1152/ajprenal.00114.2004. Epub 2005 Jan 11.

    PMID: 15644490BACKGROUND

  • Nielsen S, Frokiaer J, Marples D, Kwon TH, Agre P, Knepper MA. Aquaporins in the kidney: from molecules to medicine. Physiol Rev. 2002 Jan;82(1):205-44. doi: 10.1152/physrev.00024.2001.

    PMID: 11773613BACKGROUND

  • Bouley R, Pastor-Soler N, Cohen O, McLaughlin M, Breton S, Brown D. Stimulation of AQP2 membrane insertion in renal epithelial cells in vitro and in vivo by the cGMP phosphodiesterase inhibitor sildenafil citrate (Viagra). Am J Physiol Renal Physiol. 2005 Jun;288(6):F1103-12. doi: 10.1152/ajprenal.00337.2004. Epub 2005 Jan 11.

    PMID: 15644488BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Insipidus, NephrogenicPolyuria

Interventions

Sildenafil CitrateCalcitoninsalmon calcitoninamiloride, hydrochlorothiazide drug combinationIndomethacin

Condition Hierarchy (Ancestors)

Diabetes InsipidusKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroid HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsIndoles

Results Point of Contact

Title
Melissa Cadnapaphornchai, MD
Organization
University of Colorado Denver
melissa.cadnapaphornchai@ucdenver.edu
720776263

Study Officials

  • Melissa A Cadnapaphornchai, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 12, 2018

Results First Posted

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)US(1)