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

NCT06860711 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-1252
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.

Conditions

Chronic Kidney Disease; Pediatric Urology

Keywords

NSAIDs; CKD; Pediatrics; Urology; post-surgical

Outcome Measures

Primary Outcomes (1)

• Frequency of Acute Kidney Injury

  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 ≥3 mg/dl increase, 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.

  From start of intervention, through 7 days later

Secondary Outcomes (2)

• Opiates received while inpatient

  From start of intervention, through 7 days later

• Days with elevated pain score

  From start of intervention, through 7 days later

Study Arms (2)

NSAID

EXPERIMENTAL

Participants will receive an intravenous (IV) ketorolac 0.5mg/kg/dose, 15mg maximum, for no more than 8 doses in keeping with the investigators' routine clinical practice. Participants will then receive the oral (PO) ibuprofen suspension 10mg/kg/dose, 400mg maximum. The total duration of intervention (IV + PO) will not exceed 5 days.

Drug: NSAIDs

Placebo

PLACEBO COMPARATOR

The IV formulation will be Normal Saline. The PO formulation will be compounded to have a similar look, volume, consistency and taste to the experimental medication. Participants will receive the IV formulation for no more than 8 doses. Participants will then receive the PO formulation. The total duration of intervention (IV + PO) will not exceed 5 days.

Drug: Placebo

Interventions

NSAIDs DRUG

IV formulation: ketorolac 0.5mg/kg/dose, 15mg maximum, no more than 8 doses total PO formulation: ibuprofen suspension 10mg/kg/dose, 400mg maximum Total duration (IV + PO) will not exceed 5 days.

NSAID

Placebo DRUG

IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications

Placebo

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 months of age
• diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

• Ha D, Halstead NV, Blanchette ED, Wilcox DT, Vemulakonda VM, Wood DN, Rove KO. Risk of acute kidney injury after lower urinary tract reconstruction with early NSAID therapy: A propensity matched retrospective analysis. J Pediatr Urol. 2024 Oct;20(5):911-920. doi: 10.1016/j.jpurol.2024.07.005. Epub 2024 Jul 16.

  PMID: 39089953 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Kyle Rove, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Rove, MD

CONTACT

7209758206; kyle.rove@childrenscolorado.org

Jennifer Pyrzanowski, MSPH

CONTACT

413-329-5321; Jennifer.pyrzanowski@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)