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 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 07402025-522491-89-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AKI; cardiac surgery; CKD

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events (AEs) and severe adverse events (SAEs)

  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

• Frequency of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)

  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 Outcomes (14)

• Severity of post-surgical CSA-AKI

  Within 7 days after index surgery

• Duration of post-surgical CSA-AKI

  From the timepount of index surgery to the end of surveillance 90±7 days after index surgery

• Necessity of renal replacement therapy (RRT)

  From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery

• Duration of renal replacement therapy (RRT)

  From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery

• Cardiac function on Day 90±7 days after cardiac index surgery

  At the end of surveillance 90±7 days after index surgery

Other Outcomes (7)

• Time [hours] of the Intensive Care Unit (ICU) stay.

  From enrollment to the end of surveillance after 90±7 days after index surgery.

• Concentration of Cystatine C (serum)

  Before and within 7 days after index surgery

• Concentration of NGAL (urine)

  Before and within 7 days after index surgery

Study Arms (2)

SP16-3M

ACTIVE COMPARATOR

Drug: SP16-3M

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SP16-3M DRUG

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.

SP16-3M

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual aged ≥18 years.
• Male or female.
• Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic/mitral valve surgery combined with CABG.
• Use of the CPB during surgical intervention expected.
• Written informed consent obtained from the participant.
• Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial.
• CKD Stage 2-3b with eGFR ≤90 and ≥30 ml/min/1.73 m2 (according to 2021 CKD-EPI equation) known for ≥ 3 months prior to enrollment
• BMI ≥19 kg/m² to ≤40 kg/m².
• Contraceptive measures:
• Female participants must fulfil at least one of the following criteria of highly effective contraception (according to CTFG recommendations v1.2) during and up to 3 months after the end of study participation:
• Menopause (at least 12 months of natural amenorrhoea or 6 months of amenorrhoea with serum FSH \>40 mU/ml) OR
• Condition after bilateral ovariectomy or hysterectomy for at least 6 weeks prior to the screening appointment (Visit 1a, Day 54 to -2) OR
• Regular, correct and reliable use of a contraceptive method with an error rate ≤1% per year:
• Inhibition of ovulation by estrogen and progesterone combination preparations (oral, intravaginal, or transdermal) or
• Inhibition of ovulation by progesterone monopreparations (oral, per injectionem \[depot injections\], or implant) or

You may not qualify if:

• CKD stages 4-5 with eGFR \<30 ml/min/1.73 m2 pre-surgery as determined by CKD EPI.
• Previous cardiac surgery.
• Person has a kidney transplant or another solid organ transplant.
• Person is scheduled for intermittent or continuous renal replacement therapy (dialysis).
• Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding.
• Known diagnosis of severe COPD (Gold 3) and/or FEV1 \< 1 l/s.
• Heart failure with severity of symptoms according to NYHA IV.
• Heart failure with impaired cardiac pump function (LVEF \<35%).
• Acute onset or ongoing sepsis - sepsis is defined as the presence of a confirmed or putative infection, along with a dysregulated systemic immune reaction leading to organ dysfunction.
• Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment.
• Clinical signs of an acute viral infection.
• Serious underlying disease(s) or very poor general medical condition, so that in the investigator's judgment the person is not expected to survive ICU or hospital stay.
• Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
• Administration of iodinated contrast agent within 24 hours prior to cardiac surgery
• Recent (discontinued in the last 14 days before V1a or V1b) or current treatment with immunosuppressive drugs, including, but not limited to, high dose corticosteroids \[\> 1 mg/kg of prednisone equivalent\], tumour necrosis factor alpha blockers, or ciclosporin.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Serpin Pharma, LLC: collaborator

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Links

• Approved study protocol by the European Medicines Agency (EMA)

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Mario Schiffer

CONTACT

+4991318539002; med4@uk-erlangen.de

Tilman Jobst-Schwan

CONTACT

med4@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 22, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-02

Locations

DE (1)