Primary vesicoureteric reflux (VUR) is the most common urological abnormality in children, with a prevalence of about one percent, which increases to 30%- 40% when diagnosed after febrile urinary tract infection (UTI). VUR predisposes to UTI and is associated with renal scarring, which may cause hypertension, proteinuria, and progressive renal damage. The current treatment of VUR is long-term antimicrobial prophylaxis with surgical intervention in selected cases. However, there has been no well-designed prospective study to validate that this management is beneficial to the patient. In December 2005, NIH/NIDDK initiated the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) study, which is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrent UTI and renal scarring in children with grade l-IV VUR. The study subjects are also evaluated for bacterial resistance, constipation, voiding dysfunction, changes in renal function, quality of life, medication compliance, and the utilization of health resources. Blood and urine repository samples are collected for genetic and other ancillary studies. To test the study hypotheses, a total of 600 children will be randomly assigned to daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo (300 in each group) and followed for a 2-year period. The recruitment for the study started in May 2007 and as of November 6, 2009, 373 (62%) patients have been randomized, which includes 68 (57%) of the 120 patients to be recruited from Detroit Core Clinical Site. Based on the current recruitment projections, the 600th participant will be randomized by December 2010, who will need to be followed until December 2012. However, the current funding for the RIVUR study expires in May 2010. The main objective of this application is to obtain funding to ensure continued patient enrollment, evaluation, follow-up, and data collection for a successful completion of this very important and uniquely designed study, which has already randomized the largest number of best defined cohort of young children ever collected for a double-blind, placebo controlled, study on VUR.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (M2))
Program Officer
Moxey-Mims, Marva M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Wayne State University
Schools of Medicine
United States
Zip Code
Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Recurrent Urinary Tract Infections in Children With Bladder and Bowel Dysfunction. Pediatrics 137:
Schwaderer, Andrew L; Wang, Huanyu; Kim, SungHwan et al. (2016) Polymorphisms in α-Defensin-Encoding DEFA1A3 Associate with Urinary Tract Infection Risk in Children with Vesicoureteral Reflux. J Am Soc Nephrol 27:3175-3186
Mattoo, Tej K; Chesney, Russell W; Greenfield, Saul P et al. (2016) Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial. Clin J Am Soc Nephrol 11:54-61
Mattoo, Tej K; Carpenter, Myra A; Moxey-Mims, Marva et al. (2015) The RIVUR trial: a factual interpretation of our data. Pediatr Nephrol 30:707-12
Bhatnagar, Sonika; Hoberman, Alejandro; Kearney, Diana H et al. (2014) Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila) 53:151-7
Hoberman, Alejandro (2014) The research home: partnering with families. Acad Pediatr 14:549-53
RIVUR Trial Investigators; Hoberman, Alejandro; Greenfield, Saul P et al. (2014) Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med 370:2367-76
Chesney, Russell W; Patters, Andrea B (2013) Childhood vesicoureteral reflux studies: registries and repositories sources and nosology. J Pediatr Urol 9:731-7
Carpenter, Myra A; Hoberman, Alejandro; Mattoo, Tej K et al. (2013) The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux. Pediatrics 132:e34-45
Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika et al. (2013) Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters. JAMA Pediatr 167:561-6

Showing the most recent 10 out of 14 publications