Trial Outcomes & Findings for Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients (NCT NCT00782639)
NCT ID: NCT00782639
Last Updated: 2012-01-26
Results Overview
The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
TERMINATED
PHASE4
23 participants
48 to 72 hours After Injection of Contrast Media
2012-01-26
Participant Flow
This study was conducted in 4 investigational centers in China. The first subject was enrolled on 24 March 2009, and the last subject completed the study on 06 September 2009.
Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN (patients with Stage 3 or 4 CKD \[men: SCr level of ≥1.5 mg/dL; women: ≥1.3 mg/dL or eGFR between 15 and 50 mL/min\]) \& Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures.
Participant milestones
| Measure |
Iopamiro-370
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients
Baseline characteristics by cohort
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 to 72 hours After Injection of Contrast MediaThe number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Outcome measures
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
The Number of Participants With Contrast-induced Nephropathy (CIN)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast mediaOnly 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Outcome measures
| Measure |
Iopamiro-370
n=1 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
Baseline
|
1.10 milligrams per deciliter (mg/dL)
|
—
|
|
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
48 to 72 hours After Injection of Contrast Media
|
1.60 milligrams per deciliter (mg/dL)
|
—
|
|
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
Change from Baseline
|
0.50 milligrams per deciliter (mg/dL)
|
—
|
SECONDARY outcome
Timeframe: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast mediaThis outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
Outcome measures
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast mediaThis outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
Outcome measures
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 to 72 hours after injection of contrast mediaThis outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.
Outcome measures
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
Number of Participants Requiring Dialysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)This outcome measure provides the total number of participants who died as a result of acute renal failure.
Outcome measures
| Measure |
Iopamiro-370
n=12 Participants
(Iopamidol injection at the 370 mgI/mL concentration)
|
Visipaque 320
n=11 Participants
(Iodixanol injection at the 320 mgI/mL concentration)
|
|---|---|---|
|
Number of Participants Who Died From Acute Renal Failure
|
0 Participants
|
0 Participants
|
Adverse Events
Iopamiro-370
Visipaque 320
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
- Publication restrictions are in place
Restriction type: OTHER