RecruitingPhase 4

Safety of Short-course of NSAIDs in Pediatric Patients With CKD

United States80 participantsStarted 2025-07-22

Plain-language summary

The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.

Who can participate

Age range18 Months

SexALL

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Inclusion Criteria: * Patients over 18 months of age * diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery Exclusion Criteria: * diagnosis of CKD stage 1 or 4-5 * home medications of angiotensin converting enzyme inhibitors (ACEi, such as lisinopril or captopril) or angiotensin receptor blocker (ARB, such as losartan, valsartan) diuretics, or trimethoprim * IV contrast in last 30 days * PMH of renal transplant, diabetes, hypertension, nephrotic syndrome or heart failure, asthma, or hyperthyroidism * history of hyperkalemia * recent glucocorticoid exposure * procedure for oncologic indications * ongoing viral or fungal infection, or chemotherapy * allergy to NSAIDs

What they're measuring

Frequency of Acute Kidney Injury

Timeframe: From start of intervention, through 7 days later

Trial details

NCT IDNCT06860711

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Kyle Rove, MD

7209758206 kyle.rove@childrenscolorado.org

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