Trial Outcomes & Findings for A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications (NCT NCT00347022)
NCT ID: NCT00347022
Last Updated: 2013-04-09
Results Overview
The variation of creatinine clearance before and after the product injection was measured
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
145 participants
Primary outcome timeframe
between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration
Results posted on
2013-04-09
Participant Flow
First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)
Any patient having a creatinine clearance \< 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial
Participant milestones
| Measure |
Xenetix
Patient will receive one injection of Xenetix 300
|
Visipaque
Patient will receive one injection of Visipaque 270
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
71
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
Baseline characteristics by cohort
| Measure |
Xenetix
n=74 Participants
Patient will be injected with Xenetix 300
|
Visipaque
n=71 Participants
Patient will be injected with Visipaque 270
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
74 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
8.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
8.4 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
59 participants
n=5 Participants
|
56 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administrationThe variation of creatinine clearance before and after the product injection was measured
Outcome measures
| Measure |
Xenetix
n=62 Participants
Patient will receive one injection of Xenetix 300
|
Visipaque
n=66 Participants
Patient will receive one injection of Visipaque 270
|
|---|---|---|
|
Creatinine Clearance
|
1.1 percent change
Standard Deviation 19.7
|
1.9 percent change
Standard Deviation 22.0
|
Adverse Events
Xenetix
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Vispaque
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xenetix
n=74 participants at risk
Patient will be injected with Xenetix 300
|
Vispaque
n=71 participants at risk
Patient will be injected with Visipaque 270
|
|---|---|---|
|
Surgical and medical procedures
Surgery of vesical wound
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Blood and lymphatic system disorders
Myelofibrosis
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Meningitis
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Surgical and medical procedures
Ent surgery
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Surgical and medical procedures
Mastoidectomy
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Operation of the mediastinal haematoma
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Surgical and medical procedures
Abdominal operation
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Inflammatory syndrome
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Pyramidal syndrom
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
Other adverse events
| Measure |
Xenetix
n=74 participants at risk
Patient will be injected with Xenetix 300
|
Vispaque
n=71 participants at risk
Patient will be injected with Visipaque 270
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Headache
|
1.4%
1/74 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Increase of creatinine
|
5.4%
4/74 • Number of events 4
|
9.9%
7/71 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Allergic cutaneous reaction
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cutaneous eruption
|
2.7%
2/74 • Number of events 2
|
0.00%
0/71
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/74
|
2.8%
2/71 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Fever
|
1.4%
1/74 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Extravasation
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Oedema neck and face
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Tracheitis
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Vagal discomfort
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Warmth at the site of injection
|
0.00%
0/74
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Red papules on the arm
|
1.4%
1/74 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/74 • Number of events 1
|
0.00%
0/71
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee * Draft of publication to be submitted by the coordinating investigator (no more than 6 months after getting study results) to sponsor and other investigators for review at least 1 month before the submission to the scientific review. Comments to be reviewed and approved by the coordinating investigator and sponsor. * Each investigator agrees not to publish the comparison of the renal tolerance involving only the patients he/she has included.
- Publication restrictions are in place
Restriction type: OTHER