Evaluation of the preventive effect of intravenous trans-sodium crocetinate followed by oral crocetin on contrast-induced nephropathy in patients with chronic kidney disease undergoing coronary angioplasty: A randomized placebo-controlled triple-blind clinical trial

Salari, Sofia; Mohammadpour, AmirHooshang; Gholoobi, Arash; Ghavami, Vahid; Ramezani, Javad; Eshraghi, Ali; Hosseinzadeh, Hossein

doi:10.22038/ajp.2025.26669

Evaluation of the preventive effect of intravenous trans-sodium crocetinate followed by oral crocetin on contrast-induced nephropathy in patients with chronic kidney disease undergoing coronary angioplasty: A randomized placebo-controlled triple-blind clinical trial

Articles in Press

Document Type : Original Research Article

Authors

¹ Department of Clinical Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

² Department of Cardiovascular Diseases, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

³ Department of Biostatistics, Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

⁴ Pharmacology

10.22038/ajp.2025.26669

Abstract

Objective: Contrast media (CM) can potentially cause nephropathy. Trans-sodium crocetinate (TSC) has shown promising antioxidant and anti-inflammatory properties in animal studies. This research sought to assess TSC efficacy in contrast-induced nephropathy (CIN) prevention.
Materials and Methods: A randomized triple-blind trial involving 130 patients undergoing elective PCI (percutaneous coronary intervention) was conducted. Participants received either TSC (0.5 mg/kg) before the procedure, followed by crocetin tablets thrice daily for five days to evaluate its impact on CIN occurrence, or a placebo. The primary outcome was the occurrence of CIN, with secondary outcomes including blood urea nitrogen (BUN), serum creatinine (SCr), glomerular filtration rate (GFR), C-reactive protein (CRP), urine albumin-to-creatinine ratio (ACR), and prooxidant-antioxidant balance (PAB) test in a 5-day follow-up.
Results: The study's primary outcome revealed a significantly lower CIN prevalence in the TSC group (7.7%) compared to the placebo group (24.6%) (p = 0.009). Secondary outcomes showing significant inter-group differences included BUN (p<0.001), GFR (p<0.05), CRP (p<0.001), ACR (p<0.05), and PAB test (p<0.05). However, SCr and adverse effects did not differ significantly between the groups.
Conclusion: TSC demonstrated its ability to impede nephrotoxic processes and significantly reduce CIN incidence. Additional clinical studies are required to further validate the beneficial effects in this context.

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