An interventional study of placebo and atorvastatin in Nephropathy, sponsored by University of Oklahoma. Terminated at 2 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults > 18 years of age
end-stage renal disease on dialysis
Drug: atorvastatin
Drug: placebo
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours
Time frame: 48 hours
Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.
| Milestone | Atorvastatin | Placebo |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours
No measurements were reported for this outcome.
Collected over Not applicable/study was terminated prior to randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin | — | — | — |
| Placebo | — | — | — |
Participants signed consent; however, study was terminated prior to randomization.
| Age, Categorical | Atorvastatin | Placebo | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Atorvastatin | Placebo | Total |
|---|
| Sex: Female, Male | Atorvastatin | Placebo | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Region of Enrollment(participants) | Atorvastatin | Placebo | Total |
|---|
Plan to share: No — No data was collected; therefore, a plan is not applicable.
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Oklahoma