Trial · NCT01098032
RenalGuard System and Contrast Media
NCT01098032, Phase 3, Completed, Clinica Mediterranea; results first posted 2015-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RenalGuard System and Contrast Media. Trials, record NCT01098032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01098032
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RenalGuard System and Contrast Media
- NCT number
- NCT01098032
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 294 participants, actual
- Lead sponsor
- Clinica Mediterranea
- Conditions
- Chronic Kidney Disease
- Interventions
- RenalGuard system, Systemic alone therapy
- First posted
- 2010-04-02
- Last updated
- 2022-03-22
- Results first posted
- 2015-03-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Contrast-induced Acute Kidney Injury | at 48 hours following contrast exposure | The primary outcome measure will be the rate of development of CI-AKI in the 2 study arms (number of participants). CI-AKI is defined as an increase in the serum creatinine concentration \>=0.3 mg/dL from the baseline value at 48 hours after administration of the contrast media or the need for dialysis. |
| Secondary | Rate of Kidney Injury and Major Adverse Events | 7 days | an increase in the serum creatinine concentration \>=0.25% and \>=0.5 mg/dl at 48 hours after contrast exposure |
| Secondary | Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure | 7 days | Cystatin C is an alternative biomarker of kidney damage. Cystatin C seems to be superior to serum creatinine an identifying kidney function and damage. |
| Secondary | Changes in the Urine and Serum NGAL Concentration After Contrast Exposure | 7 days | NGAL is a new biomarker which seems to be very promising in detecting kidney injury. prelimiary data suggest that urine and serum NGAL increase very early (within few horurs) after the occurrence og acute kidney damage. Therefore, NGAL may be a real marker of acute kidney injury. |
| Secondary | the Rate of Acute Renal Failure Requiring Dialysis | 1 month | occurrence of renal failure requiring dialysis represents the haard endpoint of the study. Actually this represents the worst clinical consequence of CI-AKI. |
| Secondary | The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema) | 1 month | Assessment of the rate of in-hospital major adverse events (i.e. acute myocardial infarction, c) renal failure requiring dialysis, and d) acute pulmonary edema) will give important informantion on the clinical relevance of prophylactic strategies in preventing CI-AKI |
| Secondary | The Cost-effectiveness Ratio. | 1 month | Assessement of the cost-effectiveness ratio is important when testing a new strategy of both therapy and prophylaxis. The Renalguard system is more expensive than the conventional hydration regimen. The cost of RenalGuard system is approximately 800 $. This cost will be justified only if the system is more effective in preventing CI-AKI and improving the clinical outcome, expecially reducing the lenght of ospedalization and the rate of dialysis. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Contrast-induced Acute Kidney Injury | at 48 hours following contrast exposure | all consecutive patients with chronic kidney disease scheduled for coronary and/or peripheral angiography and/or angioplasty with an estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2 and/or a risk score ≥11 were considered eligible for the study | participants | NUMBER |
| SECONDARY | Rate of Kidney Injury and Major Adverse Events | 7 days | |||
| SECONDARY | Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure | 7 days | |||
| SECONDARY | Changes in the Urine and Serum NGAL Concentration After Contrast Exposure | 7 days | |||
| SECONDARY | the Rate of Acute Renal Failure Requiring Dialysis | 1 month | |||
| SECONDARY | The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema) | 1 month | |||
| SECONDARY | The Cost-effectiveness Ratio. | 1 month |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Contrast-induced Acute Kidney Injury | Systemic Alone Therapy Group | 146 | participants | ||
| Number of Participants With Contrast-induced Acute Kidney Injury | RenalGuard System Group | 146 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Systemic Alone Therapy Group | 147 | |
| Overall Study | STARTED | RenalGuard System Group | 147 | |
| Overall Study | COMPLETED | Systemic Alone Therapy Group | 146 | |
| Overall Study | COMPLETED | RenalGuard System Group | 146 | |
| Overall Study | NOT COMPLETED | Systemic Alone Therapy Group | 1 | |
| Overall Study | NOT COMPLETED | RenalGuard System Group | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Micturation | Renal and urinary disorders | RenalGuard System Group | 4 | 146 | 4 |
| other | Micturation | Renal and urinary disorders | Systemic Alone Therapy Group | 0 | 146 | 0 |
| other | Hypokalemia | Metabolism and nutrition disorders | RenalGuard System Group | 6 | 146 | 6 |
| other | Hypokalemia | Metabolism and nutrition disorders | Systemic Alone Therapy Group | 3 | 146 | 3 |
| serious | Death | General disorders | RenalGuard System Group | 6 | 146 | 6 |
| serious | Death | General disorders | Systemic Alone Therapy Group | 6 | 146 | 6 |
| serious | Dialysis | Renal and urinary disorders | RenalGuard System Group | 1 | 146 | 1 |
| serious | Dialysis | Renal and urinary disorders | Systemic Alone Therapy Group | 7 | 146 | 7 |
| serious | Acute pulmonary edema | Cardiac disorders | RenalGuard System Group | 3 | 146 | 3 |
| serious | Acute pulmonary edema | Cardiac disorders | Systemic Alone Therapy Group | 1 | 146 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RenalGuard System Group | ||
| Total, all-cause mortality | Systemic Alone Therapy Group | ||
| Total, other adverse events | RenalGuard System Group | 10 | 146 |
| Total, other adverse events | Systemic Alone Therapy Group | 3 | 146 |
| Total, serious adverse events | RenalGuard System Group | 10 | 146 |
| Total, serious adverse events | Systemic Alone Therapy Group | 14 | 146 |
Source ClinicalTrials.gov
Papers22
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Systemic Alone Therapy Group vs RenalGuard System Group: Number of Participants With Contrast-induced Acute Kidney Injury | Trial comparisons |
| RenalGuard System Group vs Systemic Alone Therapy Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01098032
GET https://conductscience.org/api/trials/v1/NCT01098032/papers?page=2