NSAIDs for Chronic Kidney Disease

Overseen By Catalina Hwang, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: ACEi, ARB, Diuretics, Trimethoprim

Disqualifiers: Diabetes, Hypertension, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications like ACE inhibitors, ARBs, diuretics, or trimethoprim. If you are on these, you would need to stop them to participate.

Are NSAIDs safe for people with chronic kidney disease?

NSAIDs can cause kidney problems, especially in people with chronic kidney disease (CKD). They may lead to kidney damage, and in some cases, this damage can be severe. It's important to monitor kidney function if using NSAIDs, particularly for those with CKD. ^{1 2 3 4 5}

How do NSAIDs differ from other drugs for chronic kidney disease?

NSAIDs are typically avoided in chronic kidney disease (CKD) patients due to their potential to cause kidney damage, which makes their use in this context unique compared to other treatments that are generally safer for kidney health. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Kyle Rove, MD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

This trial is for children with mild-to-moderate chronic kidney disease (CKD) who are undergoing surgery. The study aims to see if NSAIDs, commonly used for pain relief after surgery, increase the risk of acute kidney injury in these patients.

Inclusion Criteria

I am over 18 months old, have mild to moderate kidney disease, and need surgery on my urinary tract.

Exclusion Criteria

I have had high potassium levels in the past.

I am undergoing a procedure for cancer treatment.

Allergy to NSAIDs. These criteria are selected to allow valid estimations of renal function, while excluding those with a clinical history that may contribute confounding and or risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NSAID or placebo treatment for a maximum of 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute kidney injury and pain scores

7 days

Treatment Details

Interventions

• NSAIDs

Trial Overview The trial is testing the safety of a short course of NSAIDs compared to a placebo in pediatric patients with CKD post-surgery. It's designed as an initial pilot study to guide future larger-scale research on this topic.

Participant Groups

Group I: NSAID Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drug use in patients with chronic kidney disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drug use among persons with chronic kidney disease in the United States. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Non-steroidal anti-inflammatory drug induced acute kidney injury in the community dwelling general population and people with chronic kidney disease: systematic review and meta-analysis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Prescription of high-risk medications among patients with chronic kidney disease: a cross-sectional study from the Washington, Wyoming, Alaska, Montana and Idaho region Practice and Research Network. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Nephrotoxicity of nonsteroidal anti-inflammatory drugs. [2010]

6. India pubmed.ncbi.nlm.nih.gov

Retrospective pharmacovigilance analysis of nonsteroidal anti-inflammatory drugs-induced chronic kidney disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Non-steroidal anti-inflammatory drugs among chronic kidney disease patients: an epidemiological study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Association of individual non-steroidal anti-inflammatory drugs and chronic kidney disease: a population-based case control study. [2022]