Phase 3 Completed N=294 Randomized Prevention

RenalGuard System and Contrast Media

Chronic Kidney Disease

Source: ClinicalTrials.gov NCT01098032 ↗

Enrolled (actual)

294

Serious AEs

8.2%

Results posted

Mar 2015

Primary outcomePrimary: Number of Participants With Contrast-induced Acute Kidney Injury — 146; 146 participants

Summary

The purpose of the present study is to assess the role of the RenalGuard System as compared to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and very-high risk patients to prevent contrast-induced acute kidney injury contrast induced acute kidney injury (CI-AKI). Consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated glomerular filtration rate =0.3 mg/dL in the creatinine concentration 48 hours after the procedure. This study will give important answers on how to prevent CI-AKI in high and very-high risk patients undergoing contrast media exposure.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Contrast-induced Acute Kidney Injury	146; 146	—
SECONDARY Rate of Kidney Injury and Major Adverse Events	—	—
SECONDARY Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure	—	—
SECONDARY Changes in the Urine and Serum NGAL Concentration After Contrast Exposure	—	—
SECONDARY the Rate of Acute Renal Failure Requiring Dialysis	—	—
SECONDARY The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)	—	—
SECONDARY The Cost-effectiveness Ratio.	—	—

Eligibility Criteria

Inclusion Criteria

Age >=18 years
Chronic kidney disease (estimated glomerular filtration rate <=30 ml/min/1.72 m2) and/or
Risk score for contrast nephropathy ≥11 (according to the Mehran score; J Am Coll Cardiol 2004; 44: 1393-1399)

Exclusion Criteria

Pregnancy
Heart failure (NYHA functional class III-IV)
Acute pulmonary edema
Acute myocardial infarction
Recent (<=2 days) contrast media exposure
Patients enrolled in concomitant studies
Administration of theophylline, dopamine, mannitol and fenoldopam.
End-stage CKD (patients on chronic dialysis)
Systemic hypotension (systolic blood pressure < 100 mg/dl).
Multiple myeloma

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Data sourced from ClinicalTrials.gov (NCT01098032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.