A Phase 2 interventional study of SP16-3M and Placebo in AKI - Acute Kidney Injury, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2, Interventional, and Prevention
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Regular, correct and reliable use of a contraceptive method with an error rate ≤1% per year:
Male participants must fulfill at least one of the following contraceptive criteria during and up to 3 months after the end of participation in the study:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SP16-3M
Drug: Placebo
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.
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.
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.
Time frame: 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
Time frame: Within 7 days after index surgery
Severity of post-surgical CSA-AKI
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
Time frame: Within 7 days after index surgery
Duration of post-surgical CSA-AKI
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.
Time frame: From the timepount of index surgery to the end of surveillance 90±7 days after index surgery
Necessity of renal replacement therapy (RRT)
The frequency of RRT post-surgery will be recorded.
Time frame: From the timepoint of index surgery to the end of surveillance 90±7 days after index surgery
Duration of renal replacement therapy (RRT)
Duration of RRT measured by starting date \[yyyy-mmm-dd\] and end date \[yyyy-mmm-dd\]
Time frame: 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
Cardiac function on Day 90±7 days after cardiac index surgery compared to pre surgical assessment (Visit 1) assessed by transthoracic echocardiography (TTE).
Time frame: At the end of surveillance 90±7 days after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery
Cardiac function on Day 0 post-surgery (Visit 3), Day 1, and on Day 5 after index surgery assessed by point of care echocardiography (TTE) compared to pre-surgical assessment (Visit 1).
Time frame: Within 5 days after index surgery
Concentration of NT-proBNP (serum)
NT-proBNP serum concentration on Day 1, Day 7, and Day 90±7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).
Time frame: From enrollment to the end of surveillance 90±7 days after index surgery
Central venous oxygen saturation (ScvO2) (blood gas analysis)
Central venous oxygen saturation (ScvO2) on Day 1, Day 5 and Day 7 after index surgery compared to pre-surgical assessment on Day 0 (Baseline; Visit 2).
Time frame: Within 7 days after surgery
Frequency of all-cause death
Frequency of all-cause death within 90±7 days (3 months) after cardiac index surgery.
Time frame: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function
Frequency of sustained impaired renal function defined as ≥25% increase in Serum Creatinine at Day 90±7 compared to baseline.
Time frame: From the timepopint of index surgery to the end of surveillance 90±7 days after index surgery
Frequency of sustained impaired renal function requiring at least one dialysis
Frequency of sustained impaired renal function requiring at least one dialysis during the post-surgical interval until Day 90±7 (end of observation period).
Time frame: From enrollment to the end of surveillance 90±7 days after index surgery.
Frequency of AE and SAE within 7 days after cardiac index surgery.
The incidence of adverse events (AEs) and severe adverse events (SAEs) will be assessed in detail in addition to the primary outcome measure within 7 days after cardiac index surgery.
Time frame: Within 7 days after index surgery
Frequency of AE and SAE during the observation period.
Frequency of AE and SAE during the entire observation period.
Time frame: From enrollment to the end of surveillance after 90±7 days after index surgery.
Number of participants with at least one SAE
Number of participants with at least one SAE during the observation period.
Time frame: From the first timepoint of SP16 administration to the end of surveillance 90±7 days after index surgery
Time [hours] of the Intensive Care Unit (ICU) stay.
Time frame: From enrollment to the end of surveillance after 90±7 days after index surgery.
Concentration of Cystatine C (serum)
Cystatine C concentration (mg/l) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
Concentration of NGAL (urine)
urine-NGAL concentration (ng/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
Concentration of IL-6 (serum)
IL-6 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
Concentration of IL-10 (serum)
IL-10 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
Concentration of TIMP2 (urine)
TIMP2 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
Concentration of IGFBP7 (urine)
IGFBP7 concentration (pg/ml) at defined post-surgical time points within 7 days after index surgery compared to pre-surgical assessment at baseline (Visit 2).
Time frame: Before and within 7 days after index surgery
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