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

Document Type : Original Research Article

Authors

Sofia Salari ¹

AmirHooshang Mohammadpour ¹

Arash Gholoobi ²

Vahid Ghavami ³

Javad Ramezani ²

Ali Eshraghi ²

Hossein Hosseinzadeh ⁴

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.

Keywords

Saffron Trans sodium crocetinate Percutaneous coronary intervention Contrast

induced nephropathy

Subjects