Kidney Disease Research Updates
Fall 2008

Researchers Seek Children for Urinary Tract Disorder Study

Researchers conducting a study to learn if children with a urinary tract disorder known as vesicoureteral reflux (VUR) should receive extended antibiotic treatment are seeking to enroll more participants. The Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health.

Urine normally flows down to the bladder through tubes called ureters. VUR is the abnormal flow of urine from the bladder back up into the ureters. VUR is the most common functional abnormality of the urinary tract in children. Between 30 to 50 percent of children with urinary tract infections (UTIs) have VUR, which is thought to increase the risk of kidney damage when children have recurring UTIs. At least 30 percent of children who have at least one UTI will have a recurrence.

Researchers seek to enroll 600 participants in the study. Participants must be between the ages of 2 months and 6 years and have had their first UTI within the 16 weeks before their first study visit.

With the approval of 20 institutional review boards and an external data safety monitoring board charged with overseeing the safety of children in the trial, each participant receives a daily dose of an antibiotic or a placebo for up to 2 years. Children who develop recurring fever or other symptoms of infection or scar tissue buildup in the kidneys will be switched from the study to routine antibiotic care and referred to a urologist, depending on the number of infections and degree of renal scarring.

“The RIVUR study has the potential to help us understand how to provide the best care for thousands of children diagnosed every year with this condition,” said Marva Moxey-Mims, M.D., director of the NIDDK’s pediatric nephrology program in the Division of Kidney, Urologic, and Hematologic Diseases. “In addition to finding out if antibiotics reduce the risk of UTIs, we also need to understand the progression of renal scarring and the development of resistance to antibiotics in these children.”

Renal scarring occurs between 5 and 40 percent of the time when a child has a UTI. Scarring may accumulate with each infection and can lead to progressive kidney failure and the need for renal replacement therapy, such as dialysis.

About 50 years ago, physicians began to prescribe an ongoing regimen of daily antibiotics for children with VUR, based on the belief that treatment would prevent infection and reduce scarring and kidney failure. Unfortunately, the number of children developing kidney failure from VUR has not changed in that time, leading physicians to question the value of this practice and adding to concerns about increasing antibiotic resistance in the general population.

The National Kidney and Urologic Diseases Information Clearinghouse has more information about VUR at www.kidney.niddk.nih.gov/kudiseases/pubs/vesicoureteralreflux. For more information about the RIVUR study, go to www.clinicaltrials.gov/ct2/show/NCT00405704?term=RIVUR&rank=1.

NIH Publication No. 09–4531
December 2008

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