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Balcinrenone

Balcinrenone is an investigational drug being studied in clinical trials for its potential benefits in treating various kidney and heart conditions. This article summarizes key information from several ongoing clinical trials evaluating balcinrenone, both alone and in combination with other medications like dapagliflozin. The trials aim to assess the drug’s safety, efficacy, and mechanisms of action in patients with chronic kidney disease, heart failure, and related conditions.

Table of Contents

What is Balcinrenone?

Balcinrenone is a new medication currently being studied for its potential benefits in treating kidney and heart conditions. It is also known by its alternative name, AZD9977[1]. Balcinrenone belongs to a class of drugs called mineralocorticoid receptor modulators, which means it affects how the body handles certain hormones related to kidney function and fluid balance.

What Conditions Does Balcinrenone Treat?

Based on ongoing clinical trials, Balcinrenone is being investigated for the treatment of several conditions:

  • Chronic Kidney Disease (CKD): This is a condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood[2].
  • Heart Failure: A condition where the heart can’t pump blood effectively to meet the body’s needs, often accompanied by fluid retention[3].
  • Albuminuria: The presence of too much albumin (a protein) in the urine, which can be a sign of kidney damage[4].

How Does Balcinrenone Work?

Balcinrenone works by modulating (adjusting) the activity of mineralocorticoid receptors in the body. These receptors play a crucial role in regulating salt and water balance. By targeting these receptors, Balcinrenone may help:

  • Reduce fluid retention in the body
  • Lower blood pressure
  • Protect the kidneys from further damage
  • Improve heart function in people with heart failure

However, it’s important to note that the exact mechanisms are still being studied in clinical trials[5].

Balcinrenone in Combination with Dapagliflozin

Many of the current studies are investigating Balcinrenone in combination with another medication called Dapagliflozin. Dapagliflozin is a type of drug known as an SGLT2 inhibitor, which helps the body remove excess sugar through urine. The combination of Balcinrenone and Dapagliflozin is being studied to see if it provides better outcomes for patients with kidney disease and heart failure than using Dapagliflozin alone[4][5].

Current Clinical Trials

Several clinical trials are currently underway to evaluate the effectiveness and safety of Balcinrenone:

  • Hepatic Impairment Study: This study is looking at how Balcinrenone affects people with mild to moderate liver problems[1].
  • Pharmacokinetics Study in Chinese Participants: This trial is examining how Balcinrenone and Dapagliflozin are processed in the bodies of healthy Chinese individuals[2].
  • Chronic Kidney Disease Study: This larger trial is investigating the effects of Balcinrenone and Dapagliflozin on patients with chronic kidney disease and high levels of protein in their urine[4].
  • Heart Failure Study: This study is looking at how Balcinrenone and Dapagliflozin might reduce the risk of heart-related events in people with heart failure and reduced kidney function[5].

Potential Side Effects and Safety Considerations

As Balcinrenone is still in the clinical trial phase, its full range of side effects is not yet known. However, researchers are closely monitoring for any adverse events during the studies. Some areas being watched include:

  • Changes in blood pressure
  • Effects on heart rhythm
  • Changes in kidney function
  • Alterations in blood electrolyte levels (such as potassium)

It’s important to note that Balcinrenone is not yet approved for general use and is only available through clinical trials. Patients interested in this medication should discuss potential participation in clinical trials with their healthcare providers[3][5].

Aspect Details
Drug Name Balcinrenone (also known as AZD9977)
Conditions Studied Chronic Kidney Disease, Heart Failure with Impaired Kidney Function
Study Phases Phase I, Phase II, Phase III
Combination Therapy Often studied in combination with dapagliflozin
Administration Oral capsules or tablets
Dosages Studied Ranging from 15 mg to 150 mg daily
Primary Outcomes Changes in UACR, cardiovascular death risk, heart failure events
Safety Assessments Adverse events, vital signs, laboratory tests, ECG
Study Durations Varying from weeks to up to 38 months
Patient Populations Adults with chronic kidney disease, heart failure, or healthy volunteers

FAQ

  • What is balcinrenone? Balcinrenone is an investigational drug being studied for its potential benefits in treating kidney and heart conditions. It is often studied in combination with dapagliflozin, another medication used for diabetes and heart failure.
  • What conditions are being studied with balcinrenone? Clinical trials are evaluating balcinrenone for chronic kidney disease, heart failure with impaired kidney function, and its effects on body fluid and electrolyte handling in patients with these conditions.
  • How is balcinrenone administered in these trials? In the clinical trials, balcinrenone is typically administered orally, either as a single capsule or in combination with dapagliflozin. The dosages vary between trials, ranging from 15 mg to 150 mg daily.
  • What are the main goals of these clinical trials? The main goals include assessing the safety and efficacy of balcinrenone, understanding its effects on kidney function markers like urinary albumin-to-creatinine ratio (UACR), evaluating its impact on heart failure events, and studying its mechanisms of action in the body.
  • How long do these clinical trials typically last? The duration of the trials varies. Some last for a few weeks, while others are longer-term studies lasting up to 38 months. Each trial has a specific timeline designed to best evaluate the drug's effects for its intended purpose.

Ongoing Clinical Trials on Balcinrenone

  • Study on Balcinrenone and Dapagliflozin for Patients with Heart Failure and Kidney Problems

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Czechia Finland France Germany +9

  • Study on Dapagliflozin and Balcinrenone for Patients Over 50 with Stage 3 Chronic Kidney Disease

    Not recruiting

    1 1
    Investigated drugs:
    France Germany

  • Study on Balcinrenone and Dapagliflozin for Adults with Chronic Kidney Disease and Albuminuria

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Italy Poland Spain

Glossary

  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Urinary Albumin-to-Creatinine Ratio (UACR): A test that measures the amount of albumin in urine compared to creatinine, used to detect kidney damage.
  • eGFR: Estimated Glomerular Filtration Rate, a test used to check how well the kidneys are working by estimating how much blood passes through the glomeruli each minute.
  • Child-Pugh (CP) classification: A scoring system used to assess the prognosis of chronic liver disease, mainly cirrhosis.
  • SGLT2 inhibitor: A class of medications that work in the kidneys to lower blood sugar levels in people with diabetes.
  • Albuminuria: The presence of albumin (a protein) in the urine, which can be a sign of kidney damage.
  • Cardiovascular (CV) death: Death caused by heart disease or blood vessel problems.
  • Heart Failure (HF) event: An occurrence where the heart is unable to pump blood effectively, which may or may not require hospitalization.
  • Standard of Care (SoC): The best known treatment approach for a particular condition, based on scientific evidence and expert consensus.
  • KCCQ total symptom score: Kansas City Cardiomyopathy Questionnaire, a measure used to assess the health status of patients with heart failure.

References

  1. https://clinicaltrials.gov/study/NCT06388616
  2. https://clinicaltrials.gov/study/NCT06651021
  3. https://clinicaltrials.gov/study/NCT05884866
  4. https://clinicaltrials.gov/study/NCT06350123
  5. https://clinicaltrials.eu/trial/study-on-balcinrenone-and-dapagliflozin-for-patients-with-heart-failure-and-kidney-problems/