Clinical Trial Results:
A 3-Armed Prospective Randomized Controlled, Open-Labeled Phase III Trial to Evaluate Late Introduction of Cyclosporine or Everolimus versus a 5-day Delay of Cyclosporine in Combination with MMF in Liver Transplant Recipients with MELD-Scores≥25
Summary
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EudraCT number |
2009-017192-26 |
Trial protocol |
DE |
Global end of trial date |
28 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Nov 2022
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First version publication date |
04 Nov 2022
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Other versions |
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Summary report(s) |
Ergebnisbericht |
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 |
BUILT_01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Clinicaltrials.gov: NCT01023542 | ||
Sponsors
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Sponsor organisation name |
University Hospital Regensburg
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Sponsor organisation address |
Franz-Josef-Strauss-Allee 11, Regensburg, Germany, 93042
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Public contact |
Klinik und Poliklinik für Chirurgie, Universitätsklinikum Regensburg, +49 9419446801, hans.schlitt@ukr.de
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Scientific contact |
Klinik und Poliklinik für Chirurgie, Universitätsklinikum Regensburg, +49 9419446801, hans.schlitt@ukr.de
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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 |
28 May 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 May 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
28 May 2015
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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 |
The primary objective of the trial is to investigate the influence of CNI-free-“bottom up” immunosuppression compared to CNI-containing “bottom-up” immunosuppression and 5-day Cyclosporine delay and their influence on renal function at 12 months measured by estimated GFR using the abbreviated MDRD formula
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Protection of trial subjects |
see results
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Oct 2011
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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 |
Germany: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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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 |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
see results | ||||||
Period 1
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Period 1 title |
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 |
see results
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Arms
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Arm title
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Standard with CMI | ||||||
Arm description |
- | ||||||
Arm type |
see results | ||||||
Investigational medicinal product name |
Ciclosporin
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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 |
Parenteral use
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Dosage and administration details |
Ciclosporin (CsA) Gabe ab Tag 5
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Notes [1] - 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: Entgegen der initialen Planung konnten aufgrund einer geringeren Anzahl an Transplantation im oben angegeben Zeitraum insgesamt nur 22 Patienten rekrutiert werden, wobei 8 Patienten in Arm 1 und jeweils 7 Patienten in Arm 2 und Arm 3 eingeschlossen wurden |
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End points reporting groups
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Reporting group title |
Standard with CMI
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Reporting group description |
- |
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End point title |
Nierenfunktion nach 12 Monaten [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after 12 months
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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: go to Ergebnisbericht for results |
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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 |
see results
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
4
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: go to Ergebnisbericht for results |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Feb 2011 |
Recent experiences in our department showed that longer treatment intervals and higher light doses Bmay improve therapeutic and cosmetic outcome.
Visit 1 is now scheduled up to 4 weeks after the screening (last protocol version: visit 1was scheduled up to 14 days after the screening)
• Visit 2 is now scheduled 6 weeks (± 4 weeks) after visit 1 (last protocol version: visit 2 was scheduled 4 weeks after visit 1)
• Visit 3 is now scheduled 6 weeks (± 4 weeks) after visit 2 (last protocol version: visit 3 was scheduled 4 weeks after visit 2)
• Visite 4 is now scheduled 10 weeks (± 4 weeks) after visit 3 (last protocol version: visit 4 was scheduled 4 weeks after visit 3)
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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 |