Clinical Trial Results:
Test of reliability of PET-rubidium82-scan in determination of renal blood flow in healthy subjects
Summary
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EudraCT number |
2017-005008-88 |
Trial protocol |
DK |
Global end of trial date |
11 Mar 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Oct 2020
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First version publication date |
09 Oct 2020
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Other versions |
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 |
SL-2-2017
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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 |
Stine Langaa, Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest, 0045 78436587, stinlg@rm.dk
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Scientific contact |
Jesper Nørgaard Bech, Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest, 78436587 78436787, 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 |
07 Jul 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Mar 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Mar 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To test the reliability PET-rubium-82-scans in regards to determination of renal blood flow
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Protection of trial subjects |
No specific measures were put in place
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Sep 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
10
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited by advertisement in the local newspaper | ||||||||||
Pre-assignment
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Screening details |
Prior to inclusion, each participant completed a screening program. Screening consisted of a medical history; a clinical examination including measurements of weight, height, and blood pressure; electrocardiography; blood tests; urine dipstick | ||||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Two examination days | ||||||||||
Arm description |
Subjects were scanned on two separate days. On one day a single scan was performed. On another day a scan was performed before and after a 2-hour long amino acid-infusion | ||||||||||
Arm type |
order of examination days | ||||||||||
Investigational medicinal product name |
Rubidium-cloride-82
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Radionuclide generator
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
555 MBq. pr. bolus injection. 3 injections in total
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Two examination days
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Reporting group description |
Subjects were scanned on two separate days. On one day a single scan was performed. On another day a scan was performed before and after a 2-hour long amino acid-infusion |
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End point title |
Unstimulated K1 - right kidney [1] | ||||||||
End point description |
K1 is calculated for each kidney using the abdominal aorta as input function in the 1-tissue compartment model
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End point type |
Primary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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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: Data is presented as mean +/- standard deviation |
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No statistical analyses for this end point |
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End point title |
Unstimulated K1 - left kidney [2] | ||||||||
End point description |
K1 is calculated for each kidney using the abdominal aorta as input function in the 1-tissue compartment model
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End point type |
Primary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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Notes [2] - 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: Data is presented as mean +/- standard deviation |
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No statistical analyses for this end point |
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End point title |
Stimulated K1 - right kidney [3] | ||||||||
End point description |
K1 is calculated for each kidney using the abdominal aorta as input function in the 1-tissue compartment model
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End point type |
Primary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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Notes [3] - 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: Data is presented as mean +/- standard deviation |
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No statistical analyses for this end point |
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End point title |
Stimulated K1 - left kidney [4] | ||||||||
End point description |
K1 is calculated for each kidney using the abdominal aorta as input function in the 1-tissue compartment model
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End point type |
Primary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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Notes [4] - 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: Data is presented as mean +/- standard deviation |
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No statistical analyses for this end point |
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End point title |
Day-to-day variation - right kidney | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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No statistical analyses for this end point |
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End point title |
Day-to-day variation - left kidney | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At the end of the trial when all subjects have completed the days of examination
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
For each subject: From the first injection untill the last injection has been given
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Assessment type |
Non-systematic | ||||||||||||||||
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 |
Examination days
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Reporting group description |
- | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||
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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 |