Chronic Kidney DiseasePhase 4NCT06860711
Safety of Short-course of NSAIDs in Pediatric Patients With CKD
A Phase 4 study testing NSAIDs in people with Chronic Kidney Disease and Pediatric Urology, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 25 years
- Conditions the study is for
- Chronic Kidney Disease, Pediatric Urology
- What is being tested?
- NSAIDs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Jennifer Pyrzanowski, MSPH, 4133295321, jennifer.pyrzanowski@cuanschutz.edu
Gemma Beltran, MPH, gemma.beltran@cuanschutz.edu
About this study
Official title: Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
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.
- Conditions
- Chronic Kidney Disease, Pediatric Urology
- Being tested
- NSAIDs, Placebo
- Keywords
- NSAIDs, CKD, Pediatrics, Urology, post-surgical
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDsDrug
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.
PlaceboDrug
IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ≥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.
Measured: From start of intervention, through 14 days later
Secondary outcomes (2)
Opiates received while inpatient
Opiate use will be calculated as morphine equivalents per day, adjusted for weight.
Measured: From start of intervention, through 7 days later
Days with elevated pain score
Pain scores will be assessed using the Faces Pain Scale - Revised (FPS-R) or the visual analogue scale (VAS) depending on age, per nursing routine. The former is used for patients aged 4-8 years, and latter for patients aged 9 and older. These have previously been shown to be interchangeable. Both pain scales have a range from 0-10, with 10 being the worst. This metric will not be captured for patients under 4 years of age. The percentage of days with severe, or a pain score greater than 7 will be reported.
Measured: From start of intervention, through hospitalization up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start22 Jul 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Rove, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860711
- Sponsor's protocol ID
- 24-1252
- Status last verified
- Oct 2025
- First submitted
- 28 Feb 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39089953Xiang AH, Hwang CK, Clennon E, To T, Pyrzanowski J, Calderon AB, Wilson S, Shields E, Beltran G, Sevick C, Bock M, Harris KT, Rove KO. Safety of short-term non-steroidal anti-inflammatory drug use in the postoperative setting in paediatric patients with chronic kidney disease: protocol for a randomised, placebo-controlled trial. BMJ Open. 2026 Sep 18;16(9):e120782. doi: 10.1136/bmjopen-2026-120782.
PubMed 42760073
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06860711
- Acronym / sponsor ID
- 24-1252
- Conditions
- Chronic Kidney Disease, Pediatric Urology
- Keywords
- NSAIDs, CKD, Pediatrics, Urology, post-surgical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID | Experimental | Drug: NSAIDsParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDsIV 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. | Drug | NSAID |
| PlaceboIV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications | Drug | Placebo |
Primary outcome
Frequency of Acute Kidney Injury
Time frame: From 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.
2 secondary outcomes
Opiates received while inpatient
Time frame: From start of intervention, through 7 days later
Days with elevated pain score
Time frame: From start of intervention, through hospitalization up to 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 39089953Ha 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.
- Derived from this study: PubMed 42760073Xiang AH, Hwang CK, Clennon E, To T, Pyrzanowski J, Calderon AB, Wilson S, Shields E, Beltran G, Sevick C, Bock M, Harris KT, Rove KO. Safety of short-term non-steroidal anti-inflammatory drug use in the postoperative setting in paediatric patients with chronic kidney disease: protocol for a randomised, placebo-controlled trial. BMJ Open. 2026 Sep 18;16(9):e120782. doi: 10.1136/bmjopen-2026-120782.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Rove, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NSAIDs in people with Chronic Kidney Disease and Pediatric Urology, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle Rove, MD (7209758206, kyle.rove@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Acute Kidney Injury (time frame: From start of intervention, through 14 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.