NSAIDs for Chronic Kidney Disease

Overseen By Jennifer Pyrzanowski, MSPH

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using NSAIDs (a type of pain reliever) after surgery affects kidney function in children with mild-to-moderate chronic kidney disease (CKD). Researchers believe NSAIDs do not increase the risk of acute kidney injury (AKI) in these cases. Participants will receive either NSAIDs or a placebo, which mimics the real medication but has no medical effect, over five days. Children with a history of CKD who have not recently used certain medications like ACE inhibitors or angiotensin blockers might be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

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.

What is the safety track record for NSAIDs?

Research shows that NSAIDs, a type of pain reliever, can pose risks for people with kidney problems. Some studies have found that long-term use of these drugs can lead to kidney issues. For example, taking NSAIDs daily for over a year might increase the risk of developing chronic kidney disease (CKD).

However, evidence also indicates that short-term use might not be as harmful. One study found no increased risk of sudden kidney problems in patients who had certain kidney surgeries and used NSAIDs. This suggests that short-term use, as in this trial, might be safer.

This trial is in a later stage, indicating that substantial information about the safety of NSAIDs already exists. Participants should consider both the potential risks and the existing data before deciding to join the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for chronic kidney disease, which often focus on managing symptoms and slowing disease progression, the investigational use of NSAIDs like ketorolac and ibuprofen offers a new approach. These NSAIDs are being explored for their potential to provide rapid relief from inflammation and pain, which are common in chronic kidney disease patients. Researchers are excited because these treatments can be administered both intravenously and orally, potentially offering flexibility and convenience for patients. While most treatments for kidney disease require long-term use to see benefits, NSAIDs could offer noticeable effects within just a few days, which is a significant shift in managing this condition.

What is the effectiveness track record for NSAIDs in treating postoperative pain in pediatric patients with chronic kidney disease?

Research has shown that certain pain relievers called NSAIDs (non-steroidal anti-inflammatory drugs) can pose risks to kidney health, particularly for individuals with chronic kidney disease (CKD). Studies have linked NSAID use to a higher likelihood of worsening kidney function. For example, people taking NSAIDs for a short period had a slightly increased risk of developing CKD. Additionally, about 1–5% of NSAID users might experience kidney problems. This trial will compare the effects of NSAIDs with a placebo to better understand their impact on kidney health in individuals with CKD. These findings suggest that while NSAIDs can relieve pain, they might not be the best choice for everyone with CKD due to potential kidney risks. ^{2 3 4 6 7}

Who Is on the Research Team?

Kyle Rove, MD

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479701/

Effects of NSAIDs on Early CKD Development: A 10-Year ... NSAID use was associated with an increased CKD risk (HR 1.46; 95% confidence interval (CI) 1.11–1.93) and faster eGFR decline. Subgroup analysis ...

2. ajkd.org ajkd.org/article/S0272-6386(20)30724-1/fulltext

NSAIDs in CKD: Are They Safe? NSAIDs are associated with adverse renal outcomes, and their risk must be weighed against the benefit of improved pain control. An accurate risk ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.114.05105

Use of Nonsteroidal Anti-Inflammatory Drugs and Risk ... The results showed that NSAID use was associated with a 1.18-fold increased risk of CKD in subjects taking NSAIDs for 1 to 89 days; and a 1.32- ...

4. nature.com nature.com/articles/s41598-025-07146-8

Renal safety of Long-Term Non-steroidal Anti-inflammatory ... It has been reported that approximately 1–5% of NSAID users develop acute renal complications and chronic renal diseases driven by mechanisms ...

5. scientificarchives.com scientificarchives.com/article/nsaid-associated-renal-injury-mechanisms-risks-and-safer-strategies

NSAID-associated Renal Injury: Mechanisms, Risks, and ... Chronic use of NSAIDs in some patients, particularly in elderly with mildly decreased baseline kidney function, may result in progression of CKD [10]. Albeit ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8313037/

Kidney damage from nonsteroidal anti‐inflammatory drugs ... However, Melgaco et al. reported, that daily use of NSAIDs for over a year increases the risk of developing CKD.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352556825001134

Nonsteroidal anti-inflammatory drug use and acute kidney ... We found no evidence that administration of NSAIDs in patients having partial or radical nephrectomies was associated with a greater risk of acute kidney injury ...