Novartis said Thursday that it has presented TRANSFORM, a study showing that its transplant immunosuppressant Certican (Ingredient: Everolimus) has a better therapeutic effect on Asian kidney transplant patients compared to other kidney transplant patients.

The company presented its research at the Asian Transplantation Week 2018 held at Bexco in Busan.

The TRANSFORM study was the most extensive intervention study of 2,037 renal transplant recipients from 186 hospitals in 42 countries. This study was a comparative study of the combination of the controlled regimen of Certican and the reduced calcineurin inhibitor (CNI) with Mycophenolic acid and the exposure standard of CNI.

The sub-analyses in the Asian region consisted of 262 patients in eight countries, including Korea, Japan, and India. Fifty-three of the patients were Korean.

After the week 24, the proportion of patients with a baseline biologic-proven acute rejection (tBPAR) or an estimated Modification of Diet in Renal Disease Study (MDRD4) epidermal growth factor receptor (eGFR) level of less than 50ml/min/1.73m2 in the Certican group was 26.7 percent compared to the 38 percent of mycophenolic acid treatment group.

Also, the combined risk of acute rejection, graft loss, and death of the Certican group was only 8.4 percent, while the control group stood at 21.4 percent.

The company noted that such results confirmed the excellent immunosuppressive effect in the Certican group compared to the control group. The study also confirmed the significant preservation of renal function of Certican.

CNI is a standard immunosuppressant used in renal transplant patients, but it can cause renal toxicity and lead to cardiovascular comorbidities or malignant tumors if the patients go through long-term exposure.

In this study, the estimated glomerular filtration rate was maintained at all time points when the company used Certican and CNI compared with mycophenolic acid and CNI. Virus infection rates were also significantly lower in the Certican treated group.

Transplant patients can be easily infected with the virus because their immune system weakens after transplantation, while the viral infection is an essential indicator for post-transplant evaluation because of the increased risk of graft loss and death at the time of contracting diseases.

The study showed the Certican treated group showed superior results in avoiding viruses such as the BK virus and Cytomegalovirus when compared with the control group.

“The result of this TRANSFORM study confirmed the strong immunosuppressive effect of Certican as well as its preservation of renal function and reduction of viral infection,” said Professor Kim Myeong-soo of the department of transplant at Severance hospital. “Especially in Asian renal transplantation patients, the study confirmed the possibility of the drug becoming a standard treatment for patients with renal transplantation.

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