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Trial registered on ANZCTR


Registration number
ACTRN12613000195752
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
19/02/2013
Date last updated
27/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Acetazolamide in lithium-induced nephrogenic diabetes insipidus (NDI).
Scientific title
The effect of acetazolamide on
lithium-induced Nephrogenic Diabetes Insipidus
in patients with affective disorders:
a pilot study
Secondary ID [1] 281964 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lithium-induced nephrogenic diabetes insipidus 288388 0
Condition category
Condition code
Renal and Urogenital 288734 288734 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this pilot study we will evaluate the efficacy of acetazolamide in the treatment of lithium-induced NDI.
Acetazolamide will be commenced at 250mg orally once a day for 7 days, then increased to 250mg orally twice a day for the 2nd week, then as tolerated to 500mg orally twice a week for weeks 3 & 4. If the higher dose is not tolerated, the dose will be lowered back to the tolerated oral dose.Total duration of treatment is 4 weeks.
Intervention code [1] 286530 0
Treatment: Drugs
Comparator / control treatment
This is a pilot study with the individual acting as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288877 0
A change in urinary concentrating ability.
This will measured by a standard water deprivation and urinary concentration test. Following an overnight fast, a baseline urine sample will be collected at 0830. Then 40ug desmopressin (dDAVP) will be administered intranasally. Urine samples will be collected at 2,4 and 6 hours to measure urine osmolality.
This will be done at baseline and at the end of 4 week.
Timepoint [1] 288877 0
at baseline and following 4 weeks of therapy.
Secondary outcome [1] 301222 0
Patients' reported fluid intake and urine output.
Clinical assessment at each visit.
Timepoint [1] 301222 0
At baseline and at each weekly visit for 4 weeks
Secondary outcome [2] 301277 0
Assessment of blood pressure. Clinical assessment at each weekly visit
Timepoint [2] 301277 0
At baseline and at each weekly vosit for 4 weeks
Secondary outcome [3] 301278 0
Assessment of renal function by routine weekly measurement of plasma creatinine
Timepoint [3] 301278 0
At baseline and weekly for 4 weeks
Secondary outcome [4] 301279 0
Assessment of plasma lithium concentrations by weekly blood tests.
Timepoint [4] 301279 0
At baseline and weekly for 4 weeks.

Eligibility
Key inclusion criteria
stable patients treated with lithium for an affective disorder
men and women
age > 18 years
evidence of lithium- induced nephrogenic diabetes insipidus
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy
diabetes mellitus
underlying renal disorders
significant cardiac/pulmonary comorbidity
heart rhythm disorders
side effects of lithium treatment
treatment with hydrochlorothiazide or amiloride in the preceding 2 weeks
concomitant treatment with other diuretics
hypotension (systolic blood pressure < 100 mm Hg)
renal insufficiency
hypo/hyperkalemia
hypercalcaemia
hypo/hyperthyroidism

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A pilot study of individuals with lithium-induced NDI. Each individual acts as their own control with a baseline study before treatment and then a repeat study 4 weeks after acetazolamide therapy. This is an open label pilot study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics

The continuous variables will be presented as means (SD) or as percentages.

Interim analysis

After analyzing three patients in this pilot study results will be analyzed. The main parameter which will be analyzed is maximal urine osmolality. The maximal urine osmolality after acetazolamide treatment will be compared with the maximal urine osmolality before the acetazolamide treatment.

After finishing the study, maximal urine osmolality after acetazolamide treatment will be compared with the maximal urine osmolality before the acetazolamide treatment by using a paired t-test; p-values <0.05 will be considered significant.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
4/03/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
22/05/2013
Date of last data collection
Anticipated
Actual
30/08/2013
Sample size
Target
6
Accrual to date
Final
3
Recruitment outside Australia
Country [1] 4868 0
New Zealand
State/province [1] 4868 0

Funding & Sponsors
Funding source category [1] 286740 0
University
Name [1] 286740 0
Department of Medicine (Renal) research funds
Country [1] 286740 0
New Zealand
Primary sponsor type
University
Name
Department of Medicine University of Otago
Address
Department of Medicine
University of Otago Dunedin
PO Box 913 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 285518 0
None
Name [1] 285518 0
Address [1] 285518 0
Country [1] 285518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288814 0
Southern Region Health and Disability Ethics Comittee
Ethics committee address [1] 288814 0
Ethics committee country [1] 288814 0
New Zealand
Date submitted for ethics approval [1] 288814 0
14/02/2013
Approval date [1] 288814 0
18/04/2014
Ethics approval number [1] 288814 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37898 0
Prof Robert Walker
Address 37898 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9054
Country 37898 0
New Zealand
Phone 37898 0
+6434740999
Fax 37898 0
+6434747641
Email 37898 0
rob.walker@otago.ac.nz
Contact person for public queries
Name 37899 0
Robert Walker
Address 37899 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9054
Country 37899 0
New Zealand
Phone 37899 0
+6434740999
Fax 37899 0
+6434747641
Email 37899 0
rob.walker@otago.ac.nz
Contact person for scientific queries
Name 37900 0
Robert Walker
Address 37900 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9054
Country 37900 0
New Zealand
Phone 37900 0
+6434740999
Fax 37900 0
+6434747641
Email 37900 0
rob.walker@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLithium-induced NDI: Acetazolamide reduces polyuria but does not improve urine concentrating ability.2017https://dx.doi.org/10.1152/ajprenal.00147.2017
N.B. These documents automatically identified may not have been verified by the study sponsor.