Clinical Trial Results:
Differences in response to treatment with mycophenolic acid (MPA).
Summary
|
|
EudraCT number |
2009-014997-16 |
Trial protocol |
AT |
Global end of trial date |
03 Jun 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
26 Feb 2021
|
First version publication date |
26 Feb 2021
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
MPASNP1
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Medical University of Vienna
|
||
Sponsor organisation address |
Waehringer Guertel 18-20, Vienna, Austria,
|
||
Public contact |
Division of Nephrology and Dialysis, Medical University of Vienna, 0043 14040043890, guerkan.sengoelge@meduniwien.ac.at
|
||
Scientific contact |
Division of Nephrology and Dialysis, Medical University of Vienna, 0043 14040043890, guerkan.sengoelge@meduniwien.ac.at
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Interim
|
||
Date of interim/final analysis |
18 Sep 2020
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
03 Jun 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Detection of functionally relevant SNPs in IMPDH 2 gene.
|
||
Protection of trial subjects |
Insurance for each study subject, exclusion of minors and persons not capable of written informed consent.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Jan 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Austria: 155
|
||
Worldwide total number of subjects |
155
|
||
EEA total number of subjects |
155
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
102
|
||
From 65 to 84 years |
53
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
Adult kidney allograft recipients | ||||||
Pre-assignment
|
|||||||
Screening details |
Screening of all adult kidney allograft recipients on a consecutive Basis. Exclusion ctiteria: Pregnancy, Age below 18 years. | ||||||
Period 1
|
|||||||
Period 1 title |
Overall trial (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
Observation arm | ||||||
Arm description |
- | ||||||
Arm type |
Observation arm | ||||||
Investigational medicinal product name |
MPA
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Tablet
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
Standard dosage: 180mg-720mg bid
|
||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Overall trial
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
In this study, subjects with and without kidney transplant rejection were tested for the presence of
rs11706052 SNP by genetic sequencing.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Observation arm
|
||
Reporting group description |
- | ||
Subject analysis set title |
Overall trial
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
In this study, subjects with and without kidney transplant rejection were tested for the presence of
rs11706052 SNP by genetic sequencing.
|
|
||||||||||
End point title |
IMPDH 2 single nucleotide polymorphisms | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Within the study period beginning from the time of kidney transplantation
|
|||||||||
|
||||||||||
Statistical analysis title |
logistic regression analysis | |||||||||
Comparison groups |
Observation arm v Overall trial
|
|||||||||
Number of subjects included in analysis |
310
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other [1] | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Regression, Logistic | |||||||||
Confidence interval |
||||||||||
Notes [1] - In this study, subjects with and without kidney transplant rejection were tested for the presence of rs11706052 SNP by genetic sequencing. |
|
|||||||||||||||
Adverse events information
|
|||||||||||||||
Timeframe for reporting adverse events |
09.02.2010 - 03.06.2014
|
||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||
Dictionary name |
SNOMED CT | ||||||||||||||
Dictionary version |
2014
|
||||||||||||||
Reporting groups
|
|||||||||||||||
Reporting group title |
Adverse Event
|
||||||||||||||
Reporting group description |
- | ||||||||||||||
|
|||||||||||||||
Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |