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A study to evaluate the effect of survodutide on protein levels in the urine for patients with chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effect of survodutide, also known as BI 456906, on albuminuria, which is the presence of a protein called albumin in the urine. This condition is often associated with Chronic Kidney Disease, a long-term health condition where the kidneys do not work as well as they should. The investigation involves comparing the effects of the active medication against a placebo.

Participants in the study will receive either survodutide or a placebo through a subcutaneous injection, which is a method of delivering medication just under the skin. During the trial, different doses of the study drug may be administered. The course of the study includes regular monitoring of kidney function and various physical measurements over several months to observe changes in the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of medication
The survodutide (also known as bi 456906) medication is administered via subcutaneous injection, which is an injection given under the skin.
The dosage is 3.6 mg once every week.
Step 2
Monitoring of kidney function and health
Measurements are taken to evaluate the uacr (urine albumin-to-creatinine ratio), which is a test that checks for the amount of albumin, a type of protein, in the urine.
The uacr levels are assessed at week 32 and week 36 to observe changes from the start of the trial.
The egfr (estimated glomerular filtration rate), which is a measure of how well the kidneys are filtering waste, is measured to track changes through week 36.
For a specific group of 60 participants, an iohexol measured gfr test is conducted to provide a detailed measure of kidney filtration.
Measurements of perirenal fat and renal sinus fat (fat surrounding the kidneys), as well as subcutaneous fat (fat under the skin) and visceral fat (fat around organs), are performed using mri (magnetic resonance imaging) at week 36.
Step 3
Physical health assessments
Changes in body weight, waist circumference, and blood pressure (both systolic and diastolic) are recorded up to week 36.
Step 4
Wash-out period
Between week 36 and week 40, a 4-week wash-out period occurs, during which the effects of the medication on uacr and egfr are monitored after the medicine is no longer being taken.

Who can join the trial?

9 criteria

You must be at least 18 years old.
Your eGFR, which is a measure of how well your kidneys are filtering waste from your blood, must be between 20 and 90 mL/min/1.73m2.
Your urinary albumin to creatinine ratio, a test that checks for protein in your urine which can indicate kidney issues, must be between 30 mg/g and 3500 mg/g.
Your BMI (Body Mass Index), a measure of body fat based on your height and weight, must be 23 or higher.
Your kidney function must be stable, meaning your eGFR has not changed by more than 30% in the 3 months before joining.
You must have been taking a steady, maximum tolerated dose of an ACEi or ARB (common types of blood pressure medications that protect the kidneys) for at least 4 weeks.
If you take an SGLT2 inhibitor (a type of medication used to manage blood sugar or kidney health), you must have been on a stable dose for at least 8 weeks.
If you take an MRA (a type of medication that helps block certain hormones to protect the heart and kidneys), you must have been on a stable dose for at least 8 weeks.
You must be willing to sign an informed consent, which is a formal document stating that you understand the study details and agree to participate.

Who cannot join the trial?

28 criteria

Having a diagnosis of type 1 diabetes, which is a condition where the body does not produce insulin.
Having donated or lost 400 ml or more of blood in the 8 weeks before the first dose.
A history of drug or alcohol abuse within the last 12 months, or evidence of this found during medical tests or by the doctor.
A history of chronic pancreatitis (long-term swelling of the pancreas) or idiopathic acute pancreatitis (sudden swelling of the pancreas with an unknown cause).
A history of not following medical instructions or an unwillingness to follow the rules of this study.
Having any surgical or medical condition that the doctor believes makes participation too risky or makes it difficult to complete the study.
Women who could become pregnant and are unwilling or unable to use effective contraception (birth control) to prevent pregnancy during the study and for 8 weeks after the last dose.
Women who test positive for pregnancy during the initial medical screening.
Being vulnerable (such as being under legal guardianship) or mentally unable to understand and sign the consent forms.
A personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (specific types of rare cancers or hormone-producing tumors).
Having calcitonin levels (a hormone produced by the thyroid) that are too high.
A personal history of medullary thyroid carcinoma (a specific type of thyroid cancer) that was not related to family history.
Evidence of severe hepatic impairment (serious liver damage), which includes high levels of ALT or AST (liver enzymes), a history of hepatic encephalopathy (brain problems caused by liver failure), oesophageal varices (swollen veins in the food pipe), or a portocaval shunt (a surgical connection in the liver).
A history of severe hypersensitivity (extreme allergic reactions) or reasons why you cannot take glucagon RA or GLP-1 RA (specific types of injectable medications).
Uncontrolled arterial hypertension, which is high blood pressure where the top number is 180 or higher, or the bottom number is 110 or higher.
Having had a cardiovascular event (such as a heart attack or stroke) within 3 months before joining.
Using GLP-1RA medication for less than 12 weeks before the screening.
Using certain sensitive medications that are difficult to dose precisely, or using other similar hormone-related medications.
Having high levels of serum lipase (an enzyme that helps digest fat) in the blood.
Having an HbA1c level (a measure of average blood sugar over time) higher than 10.5%.
Having uncontrolled unstable diabetic retinopathy or maculopathy (eye damage caused by diabetes).
Having conditions that prevent an MRI scan, such as severe claustrophobia (fear of enclosed spaces), certain tattoos, pacemakers, metallic implants, or being too large for the scanner.
Being actively pregnant or breastfeeding.
A history of kidney or liver transplant.
Having an active malignancy (active cancer).
Signs of adrenal insufficiency (when the adrenal glands do not produce enough hormones).
Any condition or medicine that might change how the body absorbs, distributes, processes, or removes drugs, such as inflammatory bowel disease, recent gastrointestinal surgery, stomach ulcers, or urinary obstruction (difficulty peeing).
Participating in any other clinical trial within 3 months before the first dose.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Albert Schweitzer Ziekenhuis
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Dordrecht, The Netherlands
Bellvitge University Hospital
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L'hospitalet De Llobregat, Spain
Frisius
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Heerenveen, The Netherlands

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Investigated drugs

Survodutide (also known as BI 456906) is an experimental medication being tested to see if it can help reduce the amount of protein leaked into the urine (albuminuria) in people living with chronic kidney disease.

What is already known about the treatment

Survodutide - This medication is an experimental drug provided as a solution for injection and is administered through a shot under the skin. It is currently being studied in clinical trials to see how well it can reduce protein in the urine for people living with chronic kidney disease. The drug works by mimicking specific hormones in the body that help regulate metabolism and hunger, effectively targeting receptors to improve kidney health. It is classified as a dual agonist, meaning it acts on two different biological pathways at once to achieve its therapeutic effects.

Investigated diseases

Chronic Kidney Disease - This condition occurs when the kidneys gradually lose their ability to filter waste products from the blood. As the disease progresses, the kidneys become less efficient at maintaining the body's chemical balance and removing excess fluids. Over time, the damage can lead to an increase in protein levels in the urine. The severity of the condition often increases as the kidney function declines steadily.