RCLS and Drug Induced Kidney Injury Array (DIKI)
Drug Induced Kidney Injury (DIKI) panel is the latest innovative panel created by Randox Laboratories. It has been developed to identify four early stage markers of DIKI by screening for the biomarkers KIM-I, NGAL, Cystatin C, and Clusterin.
Drug induced nephrotoxicity is a common problem in clinical trials and clinical medicine and the incidence of drug-related acute kidney injury may be as high as 60%.1 With the success rates of phase I clinical trials sitting at just under 10% and 75 – 80 % of failures, from phase I – III, resulting from problems with efficacy and/or safety the need to improve patient safety and detect kidney injury as early as possible is vital.2
The novel Randox Drug Induced Kidney Injury Array (DIKI) test allows superior monitoring of nephrotoxicity for enhanced safety in drug development. The biomarkers have been identified as more sensitive than transitional testing methods to enhance accurate diagnosis of DIKI. The DIKI test will be able to identify the levels of toxicity present in the kidneys which is classified as one of the most common side effects of drug development trials.
In 2017, 75% to 80% of clinical trials failed due to unacceptable safety.2 The four biomarkers on the DIKI panel are recommended by the U.S. Food and Drug Administration and the European Medicines Agency. The biomarkers have been acknowledged as more sensitive than traditional creatinine and more specific for diagnosis and prediction monitoring. DIKI has a faster turn-around time than creatinine. The levels of serum creatinine take a lengthy 48 hours to rise in the urine of someone with Drug Induced Kidney Injury. Whereas the biomarkers, such as NGAL, on the new DIKI biochip from Randox, can be present in urine within hours following initial kidney insult. The Randox Biochip test is performed in under 3 hours. Randox Clinical Laboratory Services (RCLS) is a state of the art ISO 17025 accredited central laboratory with unrivalled facilities built upon Randox Laboratories experience and is Randox’s latest offering, dedicated to providing a clinical laboratory service designed to meet the time sensitive, bespoke requirements of clinical and research projects globally.
If you are facilitating a clinical trial and want to test for drug induced kidney injury RCLS is your out-sourcing testing solution. RCLS can assist you to ensure the toxicity and efficacy of your drug helping you to save money and time. With a greater understanding of human complexity, pharmaceutical companies are now focusing on developing safer drugs. The early detection of DIKI can reduce cost and time and will allow a safe drug in the market
If you are conducting a clinical trial or would like more information on RCLS contact firstname.lastname@example.org.
Randox Biosciences introduces the innovative Randox Drug Induced Kidney Injury Array (DIKI). The new panels allow superior monitoring of nephrotoxicity for enhanced safety in drug development. It has been developed to identify four early stage markers of DIKI by screening for the biomarkers KIM-I, NGAL, Cystatin C, and Clusterin which have been identified as more sensitive than transitional testing methods to enhance accurate diagnosis of DIKI.
Our Biochip Array Technology enables multiplex immunoassay testing. The DIKI panel of 4 markers is combined on a single biochip, enabling simultaneous results from each patient sample, delivering:
- Excellent inter-assay precision and required sensitivity
- Superior specificity
- Lower sample volume
- Fast turnaround time
- Safer drug development
With the number of hospitalised patients who develop a drug-induced renal problem due to the numbers of potent drugs have been added to the therapeutic arsenal in recent year1 – the DIKI can have a detrimental effect on a person’s health and wellbeing. Blakely stated that “drug-induced nephrotoxic contributes to 8 to 60% of all cases of AKI seen on the intensive care unit (ICU)”.2 Randox offers a 4-plex Drug Induced Kidney Injury test which detects early stage toxicity across the nephron, assisted through composite measurement. Earlier and more reliable detection of drug-induced kidney injury would improve clinical care and help to streamline drug-development. (Dieterle et al., 2010)3.
The poor sensitivity of serum creatinine for detecting and monitoring DIKI is well documented in academic journals. As a result, for early phase trials European Medicines Agency (EMA) and Food and Drug Administration (FDA) are encouraging the use of more novel urinary biomarkers alongside conventional safety monitoring. The new panel will be able to identify the levels of toxicity present in the kidneys which is classified as one of the most common side effects of drug development trials.
The new Randox Drug Induced Kidney Injury (DIKI) panel can help you conduct clinical trials safer and faster. For more information contact email@example.com.