Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)
This research study, called ZENITH High Proteinuria, is in its final main stage of testing. It aims to find out if a new combination medicine, Zibotentan/Dapagliflozin, works better than just Dapagliflozin alone for people with long-term kidney disease who have high levels of protein in their urine. The study will also carefully check how safe these treatments are and if people can tolerate them well. Participants will be randomly assigned to receive one of the treatments, and neither they nor their doctors will know which one they are getting (a 'double-blinded' approach). This helps ensure fair and accurate results about the new combination's potential benefits for kidney health.
At a glance
What is this study about?
This study is all about helping people with a specific type of chronic kidney disease. Chronic kidney disease means your kidneys aren't working as well as they should, and 'high proteinuria' means there's a lot of protein leaking into your urine. This can be a sign that your kidneys are under strain.
Researchers want to see if combining two medicines, Zibotentan and Dapagliflozin, is more effective than using Dapagliflozin by itself. Dapagliflozin is a medicine already used for conditions like kidney disease and diabetes. By combining it with Zibotentan, the hope is to further protect the kidneys and slow down the progression of the disease. The study will look closely at how well these treatments work in controlling protein levels and supporting kidney function.
This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. It involves a larger number of patients and is designed to confirm the treatment's benefits and safety over a longer period. The goal is to find better ways to manage chronic kidney disease and improve the health of people living with this condition.
Key takeaways
- This study explores a potential new treatment for specific chronic kidney disease patients.
- It compares a combination medicine with a single existing medicine.
- Participation involves regular check-ups and close monitoring.
- It's a 'Phase 3' study, aiming to confirm treatment effectiveness and safety.
- The study is 'double-blinded' for fair results.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must have a diagnosis of chronic kidney disease with specific kidney function levels (eGFR between 20 and 90, and a high amount of protein in your urine). You should also be taking a specific type of blood pressure medication (like ACE inhibitors or ARBs) at a stable dose.
There are certain reasons why you might not be able to join. For example, if you have severe heart failure, have been hospitalised for heart problems recently, or have had organ transplants, you wouldn't be eligible. People with Type 1 diabetes, certain heart rhythm problems, or very high or low blood pressure are also not suitable for this study. If you're a woman, you'll need to have a negative pregnancy test and either be past childbearing age or using effective contraception.
- Are you 18 years or older?
- Do you have chronic kidney disease with specific kidney function levels and high protein in your urine?
- Are you currently taking certain blood pressure medications (ACE inhibitors / ARBs) at a stable dose?
- Do you have severe heart failure or a history of recent hospitalisation for heart problems?
- Do you have Type 1 diabetes?
- For women: Are you past childbearing age, or using effective contraception and have a negative pregnancy test?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either the new combination treatment (Zibotentan/Dapagliflozin) or Dapagliflozin alone. Neither you nor your study doctor will know which treatment you are getting. You'll have regular visits to the clinic for health checks, blood and urine tests, and to make sure the medication is working well and you're not having any problems. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but clinical trials usually involve ongoing assessments and sometimes follow-up after the main treatment period.
Potential risks and benefits
Locations (296)
- Research SiteHuntsville, United States
- Research SiteSun City West, United States
- Research SiteBakersfield, United States
- Research SiteHuntington Park, United States
- Research SiteLos Alamitos, United States
- Research SiteLos Angeles, United States
- Research SiteNorthridge, United States
- Research SiteOxnard, United States
- Research SiteSan Carlos, United States
- Research SiteSan Dimas, United States
- Research SiteTarzana, United States
- Research SiteVictorville, United States
+284 more sites — see the official record for the full list.
Common questions
What is chronic kidney disease (CKD)?
Chronic kidney disease means your kidneys are damaged and can't filter your blood as well as they should, leading to waste build-up.
What does 'high proteinuria' mean?
It means you have higher than normal levels of protein in your urine, which can be a sign of kidney damage.
What is a 'Phase 3' study?
It's a large study, usually the last step before a new treatment can be approved and made available to patients.
Will I know which treatment I'm getting?
No, this is a 'double-blinded' study, so neither you nor your doctor will know which treatment you're receiving.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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