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Trial record 9 of 44 for:    Gadoxetate

Primovist / Eovist in Renally Impaired Patients (PERI)

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ClinicalTrials.gov Identifier: NCT00908596
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : August 7, 2014
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Contrast Media
Intervention Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Enrollment 357
Recruitment Details The first participant's first visit was on 21 May 2009. 35 study centers in Australia, Austria, Germany, Italy, Spain, South Korea, UK, USA, and Thailand screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist within the approved indications.
Pre-assignment Details A total of 364 participants were enrolled. Of these, 4 were withdrawn prior to magnetic resonance imaging (MRI) already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons. Participants had to have moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] 65 mL/min/1.73 m^2 or less).
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Period Title: Overall Study
Started 47 32 193 85
Completed 0 19 119 48
Not Completed 47 13 74 37
Reason Not Completed
Other reasons             46             6             2             0
Lost to Follow-up             0             1             12             4
Death             0             5             57             32
Protocol Violation             1             0             0             0
Withdrawal by Subject             0             1             3             1
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment Total
Hide Arm/Group Description Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Total of all reporting groups
Overall Number of Baseline Participants 47 32 193 85 357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 32 participants 193 participants 85 participants 357 participants
65.3  (9.55) 65.3  (12.03) 65.5  (10.88) 62.2  (13.83) 64.7  (11.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 32 participants 193 participants 85 participants 357 participants
Female
20
  42.6%
7
  21.9%
46
  23.8%
30
  35.3%
103
  28.9%
Male
27
  57.4%
25
  78.1%
147
  76.2%
55
  64.7%
254
  71.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 32 participants 193 participants 85 participants 357 participants
Caucasian 15 9 101 63 188
Black 2 1 6 2 11
Hispanic 0 1 3 0 4
Asian 27 16 56 8 107
other 3 5 27 12 47
1.Primary Outcome
Title Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
Hide Description A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
Time Frame Up to 24 months following the administration of Primovist/Eovist
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
2.Secondary Outcome
Title Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
Hide Description Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
Time Frame Up to 24 months following the administration of Primovist/Eovist
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
3.Secondary Outcome
Title Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Hide Description The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
Time Frame Immediately after Primovist/Eovist-enhanced MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
Very high 26 16 98 33
High 15 13 80 38
Moderate 5 3 12 4
Low 1 0 2 1
4.Secondary Outcome
Title Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection
Hide Description The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time Frame Immediately after Primovist/Eovist-enhanced MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
Excellent 29 20 99 34
Good 15 12 74 29
Adequate 1 0 15 8
Insufficient 0 0 1 2
5.Secondary Outcome
Title Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation
Hide Description The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time Frame Immediately after Primovist/Eovist-enhanced MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
Excellent 27 16 94 31
Good 15 16 77 34
Adequate 3 0 16 6
Insufficient 0 0 1 3
6.Secondary Outcome
Title Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization
Hide Description The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time Frame Immediately after Primovist/Eovist-enhanced MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description:
Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
Overall Number of Participants Analyzed 47 32 193 85
Measure Type: Number
Unit of Measure: Participants
Excellent 30 13 93 33
Good 12 16 79 34
Adequate 2 3 14 5
Insufficient 1 0 2 2
Time Frame Up to 24 months following the administration of Primovist/Eovist
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Hide Arm/Group Description Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
All-Cause Mortality
Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/32 (0.00%)   0/193 (0.00%)   1/85 (1.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(16.0 )
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   1/32 (3.13%)   7/193 (3.63%)   6/85 (7.06%) 
Gastrointestinal disorders         
Vomiting * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Infections and infestations         
Cellulitis * 1  0/47 (0.00%)  0/32 (0.00%)  2/193 (1.04%)  0/85 (0.00%) 
Erysipelas * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Rash pustular * 1  0/47 (0.00%)  0/32 (0.00%)  1/193 (0.52%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders         
Extremity contracture * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory distress * 1  0/47 (0.00%)  1/32 (3.13%)  0/193 (0.00%)  0/85 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermal cyst * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Dry skin * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Pruritus * 1  0/47 (0.00%)  0/32 (0.00%)  4/193 (2.07%)  2/85 (2.35%) 
Rash papular * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Skin ulcer * 1  0/47 (0.00%)  0/32 (0.00%)  0/193 (0.00%)  1/85 (1.18%) 
Pruritus generalised * 1  0/47 (0.00%)  1/32 (3.13%)  0/193 (0.00%)  0/85 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(16.0 )
The study was stopped early since the FDA released the sponsor from completing enrollment because the NSF incidence estimate was lower than the original literature–based estimate, and since enrollment quota were not feasible.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00908596     History of Changes
Other Study ID Numbers: 13701
2008-005867-33 ( EudraCT Number )
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: July 23, 2015