NCT06860711 Safety of Short-course of NSAIDs in Pediatric Patients With CKD
| NCT ID | NCT06860711 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Chronic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 164 participants in total. It began in 2025-07-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 is currently in the process of developing multi institution collaboration within a Pediatric Urology population, intended to inform future work in a larger patient population.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Kyle Rove, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Colorado
Frequently Asked Questions
Who can join the NCT06860711 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 25 Years, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06860711 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06860711 currently recruiting?
Yes, NCT06860711 is actively recruiting participants. Contact the research team at kyle.rove@childrenscolorado.org for enrollment information.
Where is the NCT06860711 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06860711 clinical trial?
NCT06860711 is sponsored by University of Colorado, Denver. The principal investigator is Kyle Rove, MD at Children's Hospital Colorado. The trial plans to enroll 164 participants.
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