NCT07661940 SP16-3M Acute Kidney Injury Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07661940—Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine (EASE-AKI)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07661940 is a hot trial to watch

Acute Kidney Injury is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07661940 is notable because it evaluates SP16-3M in a Phase 2 design while Frequency of adverse events (AEs) and severe adverse events (SAEs) will be assessed within 72 hours after index surgery and SP16 administration. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of 120 participants across Germany shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Primary: Frequency of adverse events (AEs) and severe adverse events (SAEs) will be assessed within 72 hours after index surgery and SP16 administration. (Within 72 hours after index surgery)
• Primary: Number of participants who develop CSA-AKI during hospital stay defined by Kidney Disease: Improving Global Outcomes \[organization\] (KDIGO) stage 1 or higher. If at least one of the following criteria is observed in the interval since end of index surgery and the 7-day assessment, a participant will be considered to have developed CSA-AKI: * Increase in Serum Creatinine (SCr) by ≥0.3 mg/dl (\>26.5 μmol/l) within 168±4 hours after index surgery (defined as the period since cardiopulmonary bypass \[CPB\] was terminated and systemic circulation resumed). * Increase in SCr to ≥1.5 times the baseline value, using the highest SCr value within 168±4 hours after index surgery. * Decrease in urine output \<0.5 ml/kg/h for more than 6 hours within 168±4 h after index surgery (Within 7 days after index surgery)
• Secondary: Highest CSA-AKI stage value according to the stage classification of the KDIGO-AKI (https://kdigo.org) based on serum creatinine level (mg/dl) and urinary output (ml/kg/hour) in the 7-day period after the index surgery: Stage 1: serum creatinine level 1.5 to 1.9 times baseline within 7 d OR ≥ 0.3 mg/dl (≥ 26.5 μmol/l) increase within 48 h; urine output \< 0.5 ml/kg/h for 6 h Stage 2: serum creatinine level 2.0 - 2.9 times baseline within 7 d; urine output \< 0.5 ml/kg/h for ≥ 12 h Stage 3: serum creatinine level 3.0 times baseline OR increase to ≥ 4.0 mg/dl OR Initiation of renal replacement therapy within 7 d; urine output \< 0.3 ml/kg/h for ≥ 24 h OR anuria for ≥ 12 h (Within 7 days after index surgery)
• Secondary: Number of days after post-surgical onset of CSA-AKI until re-achievement of baseline level of serum creatinine (defined as a return of creatinine to \<0.3 mg/dl above baseline value) or discharge from hospital, whichever comes first. (From the timepount of index surgery to the end of surveillance 90±7 days after index surgery)
• Secondary: The frequency of RRT post-surgery will be recorded. (From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery)

Benchmark readouts in the surrounding field

• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
• A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
• A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Not reported

Company & Deal Intelligence context: Friedrich Alexander Universität Erlangen Nürnberg — Germany — http://fau.eu

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07661940 is a focused lens on Acute Kidney Injury development. Its value will be determined by whether SP16-3M can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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