Back to search results

Safety of NSAIDs in Children with Chronic Kidney Disease

This study is looking at whether using common pain medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like ketorolac or ibuprofen after surgery is safe for children and young adults (ages 18 months to 25 years) who have mild to moderate chronic kidney disease (CKD). Researchers want to see if these medications increase the risk of acute kidney injury (AKI), which is a sudden decrease in kidney function. You could receive either NSAIDs or a placebo (an inactive substance that looks and tastes the same). To join, you must have CKD stages 2-3a, confirmed by a specific kidney function test (CKiD U25 eGFR calculator based on cystatin C), and be scheduled for urologic surgery requiring a hospital stay. The main goal is to see how often AKI occurs within 14 days after starting the intervention.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 164 participants.
What's involved
The total duration of receiving either IV or oral medication (ketorolac or ibuprofen, or placebo) will not exceed 5 days. The frequency of acute kidney injury will be measured from the start of the intervention through 14 days later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 14 days after starting the intervention to check for acute kidney injury.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06860711

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

Recruiting
PHASE4Ages 18–25InterventionalTreatment
University of Colorado, Denver
~164 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:NSAIDsPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Acute Kidney Injury
Measured over From start of intervention, through 14 days later

Conditions

Chronic Kidney Disease
Pediatric Urology

Explore related trials

Chronic Kidney Disease

NCT06860711

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Colorado

    Aurora, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kyle Rove, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Colorado

Who to contact

Kyle Rove, MD
[email protected]
7209758206
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients over 18 months of age
diagnosis of CKD stages 2-3a, confirmed by CKiD U25 eGFR calculator based on cystatin C laboratory testing within 6 months of surgery
Patient is scheduled to undergo a urologic surgery requiring admission or overnight stay in the hospital

Exclusion

Diagnosis of CKD stage 1 or 4-5
Past medical history of renal transplant
Past medical history of nasal polyp
Procedure for oncologic indications or on chemotherapy
Pregnant patient
True allergy to NSAIDs

What this trial measures

  • Frequency of Acute Kidney InjuryFrom start of intervention, through 14 days later

    Acute kidney injury (AKI) will be assessed for according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. Specifically, an AKI will be defined as a serum creatinine increase of ≥ 1.5 times baseline or ≥0.3 mg/dl increase within 48hrs, or a urine output \<0.5ml/kg/h for 6 to 12 hours. While there are 3 stages of AKI, the investigators will consider AKI a binary outcome since all stages are managed the same clinically. Urine output is recorded as a routine part of strict intake \& output monitoring by nursing. The serum creatinine will be compared to the pre-incisional/baseline data.