Clinical Trial Results:
18F-NaF PET/CT in combination with biomarkers for the classification of renal osteodystrophy in chronic kidney disease
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Summary
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EudraCT number |
2016-005160-34 |
Trial protocol |
DK |
Global end of trial date |
03 Jul 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jan 2021
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First version publication date |
02 Jan 2021
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Other versions |
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Summary report(s) |
summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MV-1-2017
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medicinsk forskning
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Sponsor organisation address |
Lægårdvej 12, Holstebro, Denmark, 7500
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Public contact |
Marie Houmaa Vrist, Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, +45 78436585, marvri@rm.dk
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Scientific contact |
Jesper N. Bech, Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, +45 78436585, Jesper.Noergaard.Bech@vest.rm.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Aug 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jun 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jul 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To investigate 18 F-NaF PET/CT in combination with biomarkers for classification of subtypes of renal osteodystrophy in patients treated with hemodialysis. This is compared to the golden standard (bone biopsy with double tetracycline labeling).
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Protection of trial subjects |
Coagulation blood samples were analyzed before bone biopsy
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Background therapy |
Tetracycline 500mg two day twice with a 10 days interval. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jan 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
34
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
19
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients from the department of Nephrology, Hostebro Hospital and Aalborg Hospital, Denmark | ||||||||||||||||||
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Pre-assignment
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Screening details |
informed constent dialysis more than 3 month | ||||||||||||||||||
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Period 1
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Period 1 title |
scan and bone biopsy (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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A one arm study | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
sodium fluride F 18
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Investigational medicinal product code |
PR1
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Other name |
NaF, 18F-NaF
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
150 MBq once at scan start
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Baseline characteristics reporting groups
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Reporting group title |
A one arm study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
A one arm study
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Reporting group description |
- | ||
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End point title |
Ki [1] | ||||||||
End point description |
Ki measured from 18-NaF PET/CT, patlak single point, semi-population input function
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End point type |
Primary
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End point timeframe |
After completed the study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is a one arm study. I will like you to look at the upcomning paper for statistical analyses |
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| No statistical analyses for this end point | |||||||||
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End point title |
Ac.F | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
End of study
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| No statistical analyses for this end point | |||||||||
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End point title |
BFR/BS | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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End point title |
Mlt. | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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End point title |
BV/TV | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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End point title |
bALP | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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End point title |
FGF23 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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End point title |
osteocalcin | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
end of study
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| No statistical analyses for this end point | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
From first tablet prescription before bone biopsy until sutures removed.
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Assessment type |
Non-systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
- | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The tracer 18F-NaF is known well tolerated for many years applied with other scan methods |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
