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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

NCT07661940 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-25

No results posted yet for this study

Summary

This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine).

SP16 is an investigational medicinal product that has not yet been approved for clinical use. To date, it has been studied in 28 individuals. The sponsor aims to evaluate whether SP16 can safely reduce or prevent kidney damage associated with the inflammatory and ischemia-reperfusion processes that may occur during cardiac surgery with cardiopulmonary bypass.

Participation in the study extends over a period of slightly more than five months. Screening procedures are performed within approximately seven weeks to two days before the scheduled surgery to determine eligibility for participation. During the hospitalization for cardiac surgery, which is expected to last approximately 10 days, a total of 11 study visits are conducted. Follow-up assessments include a telephone contact approximately one month after hospital discharge and a final on-site study visit approximately three months after discharge.

This is a randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned to receive either SP16 or a placebo, which contains no active ingredient. Neither the participants nor the investigators know which treatment has been assigned during the study period.

Based on previous preclinical and early clinical findings, SP16 may have the potential to reduce or mitigate kidney injury caused by the use of the heart-lung machine during cardiac surgery. However, since the efficacy of SP16 has not yet been proven, no clinical benefit can be guaranteed. Participants receiving placebo are not expected to derive a direct therapeutic benefit from study treatment.

Conditions

  • AKI - Acute Kidney Injury

Interventions

DRUG

SP16-3M

The IMP is injected subcutaneously at two different time points. The first administration will take place pre-surgically, in the area of the operating theatre, when the participant is under anesthesia. The second administration will be performed post-surgically, 9±1 h after the first administration. At each of the two injection timepoints, a fixed dose of 6 mg SP16-3M is administered by two s.c. injections of 2 ml (concentration 1.5 mg/ml) each at two different injection sites.

DRUG

Placebo

In the placebo group, placebo (dextrose 5%) is injected subcutaneously at the same timepoints as the IMP, each time slowly (over about 30 seconds) at a fixed volume of 2 ml each at two different injection sites.

Sponsors & Collaborators

  • Serpin Pharma, LLC

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-18
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661940 on ClinicalTrials.gov