In short
There are currently 3 ongoing clinical trials focused on renal impairment, investigating how kidney function affects medication processing and exploring treatments to improve kidney health in patients with reduced kidney function. These studies are being conducted in Germany and Sweden, examining investigational drugs such as Vonafexor, Obeldesivir, and AZD3427 in patients with varying degrees of kidney impairment.
Clinical trial locations
- Germany
- Sweden
Study on the Effects of Vonafexor, Rosuvastatin Zinc, and Iohexol on Kidney Function in Patients with Impaired Renal Function and Suspected MASH
This trial is investigating Vonafexor, a medication that may help improve kidney function in patients with reduced kidney health and suspected Metabolic Associated Steatohepatitis (MASH), a liver condition often associated with obesity and diabetes. The study uses a diagnostic agent called Iohexol to help assess how well the kidneys are working.
Who can participate: Adults aged 18 to 75 years with a body mass index between 25.0 and 45.0 kg/m² are eligible. Participants must have an eGFR (a measure of kidney function) between 30 and 90, indicating mild to moderate kidney impairment. They should also show signs of liver fibrosis based on specific test scores (FIBROTEST of 0.28 or higher and/or FIB-4 of 1.3 or higher). Individuals with type 2 diabetes can participate if their blood sugar control measure (HbA1c) is 9.5% or lower.
Who cannot participate: The trial excludes people with severe kidney problems, those with other serious health conditions that might interfere with the study, pregnant or breastfeeding individuals, and anyone who has recently participated in another clinical trial. People with allergies to the study medication, a history of drug or alcohol abuse, or those taking medications that could interact with Vonafexor are also excluded.
What the trial aims to discover: Researchers will monitor kidney function at multiple time points throughout the study, including at weeks 4, 8, 12, 16, 20, 24, and 28. The trial will measure how Vonafexor affects kidney filtration rates and assess its safety through regular laboratory tests, physical examinations, and monitoring of vital signs and heart activity.
Study on How Kidney Function Affects the Drug GS-5245 in Patients With Normal and Impaired Kidney Function
This study examines how Obeldesivir (given as GS-5245 tablets) behaves in the body depending on kidney function. The medication comes in two dosages: 175 mg and 350 mg, taken as film-coated tablets. Participants will receive a single dose and be monitored to understand how the drug is absorbed, distributed, and eliminated.
Who can participate: Adults aged 18 to 79 years with a BMI between 18.0 and 38.0 kg/m² can join. The study includes people with different levels of kidney function: those with normal kidney function (eGFR of 90 or more), mild impairment (eGFR between 60 and less than 90), moderate impairment (eGFR between 30 and less than 60), and severe impairment (eGFR between 15 and less than 30). Participants must have stable kidney function for at least 3 months before screening, and their liver enzyme levels should be no more than twice the upper limit of normal.
Who cannot participate: People who have had a kidney transplant or are currently on dialysis cannot join. The trial also excludes pregnant or breastfeeding individuals, those with other serious health conditions that might affect study results, anyone taking medications that could interfere with the study drug, and those who have recently participated in another clinical trial.
What the trial aims to discover: The study will measure medication concentrations in blood and urine to understand how kidney function affects drug processing. This information helps researchers determine if medication dosing needs adjustment for people with kidney problems, ensuring the drug can be used safely across different patient populations.
Study on the Effects of AZD3427 on Kidney Function in Heart Failure Patients with Kidney Issues
This trial focuses on AZD3427, a medication being studied for its potential to improve kidney blood flow in patients with both heart failure and reduced kidney function. The study uses Positron Emission Tomography (PET) imaging with a radioactive tracer called 15O-WATER to measure changes in blood flow to the kidneys. Some participants will receive AZD3427 while others will receive a placebo for comparison.
Who can participate: Participants must be over 20 years old with a minimum BMI of 18.0 kg/m² and body weight of at least 50 kg. They should have been diagnosed with heart failure (classified as NYHA I to III) for at least 12 months and have a left ventricular ejection fraction of 40% or less, meaning the heart isn't pumping blood effectively. Their kidney function (eGFR) should be between 30 to 90 mL/min/1.73 m². Participants must be on stable heart failure medications for at least 4 weeks before screening. Female participants must be postmenopausal or surgically sterilized, and male participants must agree to use contraception for 3 months after receiving the study medication.
Who cannot participate: The trial excludes patients with severe heart failure or serious kidney problems beyond the specified range, those outside the study's age requirements, and individuals considered part of vulnerable populations who might need special protection.
What the trial aims to discover: Researchers will use PET scans to measure the volume of the kidney's outer layer (renal cortex) with increased blood flow. The study will assess whether AZD3427 can improve kidney perfusion in patients with both heart failure and kidney impairment, monitoring safety through vital signs checks, laboratory tests, and electrocardiogram (ECG) readings throughout the trial period.
Summary
The three ongoing clinical trials for renal impairment show a diverse approach to understanding and treating kidney dysfunction. Two trials are being conducted in Germany, focusing on how kidney function affects drug processing and on potential treatments for patients with both kidney and liver issues. One trial is taking place in Sweden, specifically examining patients who have both heart failure and kidney problems.
The studies investigate three different investigational drugs: Vonafexor for patients with suspected MASH and kidney impairment, Obeldesivir to understand how kidney function affects drug metabolism, and AZD3427 for patients with both heart failure and reduced kidney function. Each trial uses different approaches, from measuring drug concentrations in blood and urine to using advanced PET imaging technology to visualize kidney blood flow.
Collectively, these trials cover a range of kidney impairment severity, from mild to severe, and address important questions about medication safety and effectiveness in patients with compromised kidney function. The research aims to provide valuable information that could help healthcare providers better tailor treatments for individuals with kidney problems.
