Clinical Trial Results:
Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in dialysis patients.
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Summary
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EudraCT number |
2017-002096-26 |
Trial protocol |
DK |
Global end of trial date |
20 Aug 2019
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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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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-3-2017
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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, Universitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, +45 78436585, Jesper.Noergaard.Bech@vest.rm.dk
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Scientific contact |
Marie Houmaa Vrist, Universitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, +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 |
06 Jan 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Aug 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Aug 2019
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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 whether treatment with an iron- or calcium-containing phosphate binder can affect differently the results from 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio. Differences in the stiffness of blood vessel assessed with applanation tonometry. Finally, we investigate changes in calcium score (TBR) and iron status
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Protection of trial subjects |
blodprøve kontroller hver 14. dag
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 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: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
5
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Deltagerne er fundet i dialyseafsnitte på regionshospitalet Holstebro | |||||||||
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Pre-assignment
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Screening details |
dialyse i mere end 3 mdr, alder mellem 18 - 75 | |||||||||
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Period 1
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Period 1 title |
Behandlingsperiode 1
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Velphoro | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Velphoro
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Chewable tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder. Fig. 2 shows the study design.
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Arm title
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Unikalk basic | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Unikalk basico
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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 |
Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder. Fig. 2 shows the study design.
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Period 2
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Period 2 title |
Behandlingsperiode 2
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Is this the baseline period? |
Yes [1] | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Velphoro | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Velphoro
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Chewable tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder. Fig. 2 shows the study design.
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Arm title
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Unikalk basic | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Unikalk basic
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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 |
Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder. Fig. 2 shows the study design.
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| Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Resultater fra dette studie er set på som et overkrydset studie og er desuden slået sommen med et tilsvarende studie med ckd3-5 patienter for at opnå brugbare resultater |
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| Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: To deltager gik ud af studiet før randomisering. Én trak sit samtykke tilbage og én fik apopleksi og blev derfor ekskluderet. |
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Baseline characteristics reporting groups
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Reporting group title |
Behandlingsperiode 2
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Reporting group description |
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End points reporting groups
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Reporting group title |
Velphoro
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Reporting group description |
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Reporting group title |
Unikalk basic
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Reporting group description |
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Reporting group title |
Velphoro
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Reporting group description |
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Reporting group title |
Unikalk basic
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Reporting group description |
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End point title |
Ki, lumbal [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
end of 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: Der var ganske få data i dette projekt, hvorfor data er behandlet sammen med et lignende projekt for at opnå brugbare data. |
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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
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Timeframe for reporting adverse events |
Fra indgift af første forsøgs-medicin til 48 timer efter indgift af sidste forsøgs-medicin.
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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 |
Velphoro
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Reporting group description |
- | ||||||||||||||
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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. | |||
| None reported | |||
