Clinical Trial Results:
Role of different phosphate binders on absorption of vitamin K, metabolism of matrix γ-carboxy-glutamaat (Gla) proteïne (MGP).
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Summary
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EudraCT number |
2013-003949-41 |
Trial protocol |
NL |
Global end of trial date |
01 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Apr 2022
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First version publication date |
09 Apr 2022
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Other versions |
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Summary report(s) |
main document |
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 |
36810
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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 |
VU medical center
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Sponsor organisation address |
De Boelelaan 1117, Amsterdam, Netherlands, 1081HV
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Public contact |
Martijn Stolk, VU medical Center, 0031 204449322, m.stolk@vumc.nl
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Scientific contact |
Martijn Stolk, VU medical Center, 0031 204449322, m.stolk@vumc.nl
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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 |
23 Mar 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Oct 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2018
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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 |
This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in intestinal tract end thereby cause different level of calcification.
Level of calcification will be measured by dp-ucMGP which is used as markers for vascular calcification. Because of the fact that ucMGP en dp-ucMGP are vitamin K dependant PIVKA-II will be measured as well.
Better insight in mechanisms of vascular calcification under different circumstance can lead to therapeutic options which inhibit calcification and benefit survival of dialysis patients
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Protection of trial subjects |
The blood work during a dialysis sessions was monitored more frequently. There was no extra pain since the blood was drawn during dialysis.
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Background therapy |
No additional products were used. | ||
Evidence for comparator |
There is evidence that lanthanumcarbonate does bind fat soluble vitamins in vivo. this was the reason to compare this drug with calcium carbonate. | ||
Actual start date of recruitment |
01 Jan 2014
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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 |
Netherlands: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
6
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
In three Dutch dialysis centers (Noord West Ziekenhuisgroep location Alkmaar, Diapriva Amsterdam, Elyse clinic Amstelveen) hemodialysis patients were enrolled. Enrollment of patients started in October 2014 and the study follow up ended in September 2018 | |||||||||
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Pre-assignment
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Screening details |
Clinically stable adult (age > 18 years) hemodialysis patients with a life expectancy of more than six months were screened. | |||||||||
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Period 1
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Period 1 title |
baseline (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
there was no blinding implemented
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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lantahnum carbonate | |||||||||
Arm description |
start with use of lantahnum carbonate | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
lanthanum carbonate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Soluble tablet
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Routes of administration |
Oral use
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Dosage and administration details |
three times a day 1000 mg for eight weeks
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Arm title
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calcium carbonate | |||||||||
Arm description |
start with calcium carbonate use | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
calciumcarbonate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
three times a day 1000 mg for eight weeks
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
baseline
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
baseline
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End points reporting groups
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Reporting group title |
lantahnum carbonate
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Reporting group description |
start with use of lantahnum carbonate | ||
Reporting group title |
calcium carbonate
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Reporting group description |
start with calcium carbonate use | ||
Subject analysis set title |
baseline
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
baseline
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End point title |
dp-uc-MGP | |||||||||||||||
End point description |
Primary end point was the difference in dp-ucMGP and PIVKA-II after 8 weeks of treatment between LC and CC.
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End point type |
Primary
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End point timeframe |
Primary end point was the difference in dp-ucMGP and PIVKA-II after 8 weeks of treatment between LC and CC.
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Attachments |
baseline laboratory parameters |
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Statistical analysis title |
difference in dp-uc-MGP between | |||||||||||||||
Statistical analysis description |
difference in dp-uc-MGP between the groups after 8 weeks of treatment
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Comparison groups |
lantahnum carbonate v calcium carbonate
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Number of subjects included in analysis |
12
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [1] | |||||||||||||||
P-value |
= 0.9 [2] | |||||||||||||||
Method |
lineair mixed model | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Confidence interval |
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| Notes [1] - cross over study, the patients that completed at least one period of 8 weeks of treatment with a binder were analysed. [2] - not significant |
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Adverse events information
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Timeframe for reporting adverse events |
2 patients got admitted to the hospital, however the admission was not a side effect of the medication.
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Adverse event reporting additional description |
1 patient got admitted with galbladder problems and other one with pneumonia.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
ABR formulier | |||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
lanthanumcarbonate
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Reporting group description |
One patient with gall bladder problems got admitted. The study medication was not a causative factor. | |||||||||||||||||||||||||||||||||||||||
Reporting group title |
calciumcarbonate
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Reporting group description |
One patient gor admitted for pneumonia. This was not due to the use of the study medication | |||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||
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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. | |||
| the number of patients that completed the trial was very small. | |||
