Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000049673
Ethics application status
Approved
Date submitted
6/01/2014
Date registered
17/01/2014
Date last updated
17/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Nitrates for bone protection in chronic kidney disease
Scientific title
Nitrates as a potential therapeutic option for bone fragility in chronic kidney disease - a randomised, double blind placebo controlled trial
Secondary ID [1] 283855 0
Nil
Universal Trial Number (UTN)
Trial acronym
NITRACKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 290832 0
Osteopenia 290833 0
Condition category
Condition code
Musculoskeletal 291196 291196 0 0
Osteoporosis
Renal and Urogenital 291197 291197 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Isosorbide dinitrate 20 mg or matching placebo once daily for 12 months as an oral tablet. Adherence will be monitored by counting of drug tablet returned.
Intervention code [1] 288533 0
Treatment: Drugs
Comparator / control treatment
Placebo (matching microcellulose tablet)
Control group
Placebo

Outcomes
Primary outcome [1] 291187 0
Spinal bone mineral density (BMD), measured by dual energy x-ray absorptiometry (DXA).
Timepoint [1] 291187 0
12 months
Primary outcome [2] 291188 0
Serum alkaline phosphatase.
Timepoint [2] 291188 0
12 months
Secondary outcome [1] 306204 0
Femoral neck, total hip and distal radius BMD, measured by dual energy x-ray absorptiometry (DXA).
Timepoint [1] 306204 0
12 months
Secondary outcome [2] 306205 0
Serum bone turnover markers (PINP and CTX)
Timepoint [2] 306205 0
12 months

Eligibility
Key inclusion criteria
Participants willl have both stage 3 or 4 CKD and either
osteopenia or osteoporosis
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Minimal trauma fractures
Uncorrected vitamin D deficiency (< 50 nmol/L)
PTH > 15 pmols/L
Metabolic bone diseases
Prednisolone > 5 mgs/d
Unexplained elevation of serum alkaline phosphatase

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised to active or placebo groups with stratification for sex. Recruitment into mild CKD will be limited to 20 (one third) using allocation concealment. The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Allocation will involve contacting the holder of the allocation schedule who will be “off-site” at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified, block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
1/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1894 0
Western Hospital - Footscray
Recruitment hospital [2] 1895 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 7669 0
3011 - Footscray
Recruitment postcode(s) [2] 7670 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 288502 0
Charities/Societies/Foundations
Name [1] 288502 0
Kidney Health Australia
Country [1] 288502 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
NorthWest Academic Centre.
176 Furlong Road
St. Albans
VIC 3021
Country
Australia
Secondary sponsor category [1] 287207 0
None
Name [1] 287207 0
none
Address [1] 287207 0
Country [1] 287207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290360 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 290360 0
Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Ethics committee country [1] 290360 0
Australia
Date submitted for ethics approval [1] 290360 0
29/01/2014
Approval date [1] 290360 0
Ethics approval number [1] 290360 0

Summary
Brief summary
Studies have consistently shown that low trauma fractures are widely prevalent among patients with chronic kidney disease (CKD). However, the management of this condition remains controversial because the safety and efficacy of most currently available treatments for the prevention of fractures have not been adequately tested in patients with CKD. Further, many of these treatments are potentially toxic to kidneys and may also have deleterious effects in certain types renal bone disease. Therefore, there is a need for investigating new therapies for bone protection in CKD, using drugs that are safe and effective in patients with CKD. Recent evidence suggests that nitrates have all the attributes to be a potential candidate for bone protection in CKD. They have been shown to have bone protective properties in postmenopausal women, although not specifically in patients with CKD, and their safety in CKD, including in patients with advanced CKD, is well established. The current study is arandomised, placebo-controlled trail designed to assess the efficacy of isosorbide dinitrate, a commonly available oral nitrate preparation in Australia, versus placebo in the prevention of spinal bone loss in patients with moderately severe kidney disease (CKD stage 3 and 4).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45334 0
Prof Peter R Ebeling
Address 45334 0
The University of Melbourne
Room 5.017, Level 3
Western Centre for Health Research and Education
Western Health
PO Box 294
176 Furlong Road
St Albans
Vic 3021
Country 45334 0
Australia
Phone 45334 0
+61383958065
Fax 45334 0
+61383958258
Email 45334 0
[email protected]
Contact person for public queries
Name 45335 0
Prof Peter R Ebeling
Address 45335 0
Room 5.017, Level 3
Western Centre for Health Research and Education
Western Health
PO Box 294
176 Furlong Road
St Albans
Vic 3021
Country 45335 0
Australia
Phone 45335 0
+61383958065
Fax 45335 0
+61383958258
Email 45335 0
[email protected]
Contact person for scientific queries
Name 45336 0
Prof Peter R Ebeling
Address 45336 0
Room 5.017, Level 3
Western Centre for Health Research and Education
Western Health
PO Box 294
176 Furlong Road
St Albans
Vic 3021
Country 45336 0
Australia
Phone 45336 0
+61383958065
Fax 45336 0
+61383958258
Email 45336 0
[email protected]

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
No additional documents have been identified.