INDIANAPOLIS — The pediatric nephrology clinical research team at the Indiana University School of Medicine has enrolled the inaugural participant in the EMPA Kidney Kids (EKK) global clinical trial, a study focused on finding a treatment for children with Chronic Kidney Disease (CKD). The site at IU and Riley Children's Health is the first in the United States to successfully randomize a patient in the trial.
CKD is a long-term condition characterized by persistent abnormalities of kidney structure or function that may impair the kidneys' ability to maintain normal health. In children, the most common cause of CKD is congenital anomalies of the kidney and urinary tract, followed by heredity and genetic kidney diseases, glomerular diseases that are acquired during adolescence, and systemic conditions or diseases that effect the kidneys. If the progression of CKD is not slowed, patients eventually face being put on dialysis or may require a kidney transplant. Currently, there are very few treatment options available to help slow the progression of CKD in pediatric patients.
A treatment that has yielded positive results in adults is the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as empagliflozin (EMPA). However, SGLT2 inhibitors have yet to be studied in the pediatric CKD population. The approval of the EKK study is generating excitement around the world about the possibility of a new treatment option for pediatric CKD.
“We have been especially excited because this medicine, in adults, has been shown to help improve certain biomarkers of kidney disease, such as albumin in the urine, and slows the decline of the kidneys in CKD,” said Neha D. Pottanat, MD, assistant professor of pediatrics at the IU School of Medicine and the trial’s principal investigator.
When albumin, a type of protein, is found in the urine, it indicates that the glomeruli, the kidneys’ filters, are damaged, which allows albumin to escape into the urine.
“When albumin in the urine is normalized, the progression of kidney disease slows, which increases the time before a child needs dialysis or a kidney transplant,” said Pottanat, who is also a pediatric nephrologist at Riley Children’s Health.
Jennifer Mullett, CRN, research coordinator for the EKK study, said being enrolled in the trial is supplemental to the patient's clinical care and that these patients may benefit from having more oversight, not just by their clinical team but by the research team as well.
“It provides them with a sense of support,” Mullett said. “We are so grateful to all our participants and families who have expressed interest in learning more, even if they decide not to participate. It's nice to have that embedded into the clinical space.”
The team is currently enrolling a second patient, and more patients and families are expressing interest in becoming a part of the EKK trial. Kiran Zehra Naqvi, MD, a clinical research specialist at IU, said she is surprised by the overwhelming interest from patients and families concerning the trial.
“When I reach out to patients about the trial, they are saying, ‘Yes. We are interested,’ and I feel this is because it’s offering them a hope they are not getting anywhere else,” Naqvi said.
For patients to be enrolled in the EKK trail, they must meet these basic eligibility criteria:
- Be a child between 2 - 17 years of age.
- Have been diagnosed with CKD, stage 2-4 (eGFR 20-90 ml/min/1.73m2).
- Have been taking medication for the condition for at least 30 days.
- Are not receiving dialysis; have not received and are not scheduled to receive a kidney transplant.
- Have not been diagnosed with Type 1 or Type 2 diabetes.
Medication is given daily in the form of a tablet pill, which can be crushed for children who cannot yet swallow tablets. The study includes 15 visits over 18 months and are supported by local laboratory testing. Up to 7 of the 15 visits are able to be conducted virtually. By reducing the need for travel to Indianapolis, this design helps lessen barriers to participation and promotes more equitable access to the trial for families across the region.
The team would like to thank the enthusiastic support of Division Chief of Pediatric Nephrology David Hains, MD, Associate Vice Chair of Clinical Trials Myda Khalid, MD, and the research team that was integral to achieving this milestone so quickly for the patients and the institution.
“The dedication to developing the clinical trial infrastructure for the division is making way for this and many future collaborations, bringing more opportunities to the IU School of Medicine and Riley communities,” Mullett said.
Families interested in learning more about the study may contact the team directly by calling 317-274-2576 or emailing Sherry Wilson at slw2@iu.edu. Find more information on the study website: www.empakidneykids-study.com
About the Indiana University School of Medicine
The IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability. According to the Blue Ridge Institute for Medical Research, the IU School of Medicine ranks No. 15 in 2025 National Institutes of Health funding among all public medical schools in the country.
Writer: Katelyn Stewart, stewar2@iu.edu
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