1366-0005 BI 685509 Diabetic KD
Research type
Research Study
Full title
Randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease
IRAS ID
294285
Contact name
Manish Saxena
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2020-002929-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
This study is a randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the efficacy, safety, tolerability and Pharmacokinetics (PK) and Pharmacodynamics (PD) of 3 oral doses of BI685509 over 20 weeks of treatment in male and female patients with Diabetic Kidney Disease (DKD) added who are treated with either Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) treatment plus local standard of care according to local guidelines.
Eligible patients will be randomised equally into one of three parallel dose groups, and in each dose group, to treatment either with BI 685509 or matching placebo in a 3:1 ratio. All patients will start on 1 mg TID BI 685509 or matching placebo. Dose groups are as follows: Dose group 1:1mg TID; Dose group 2:2mg TID; Dose group 3:3mg TID. Each dose will be taken three times a day for approximately 20 weeks. Patients participation will last approximately 28 weeks and require approximately 15 visits in a combination of investigational site, patient's home and telephone contact. A patient will undergo physical examinations,ECGs,10hour urine samples to measure Urine Albumin Creatinine Ratio (UACR), Mitra microsampling at clinic and home and various blood tests. Participants will also be required to keep 2 diaries - Daily Diary for Trial Drug Intake and The Diary for Urine and Blood Collection.
The main objectives of the trial are to demonstrate the effectiveness of BI 685509 and to characterise the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo. The primary endpoint will be to look at the change in UACR measured in the 10 hour urine, after 20 weeks of treatment.Summary of study results:
A study to test the effect of different doses of BI 685509 on kidney function in people with diabetic kidney disease
This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 685509 and the treatment of diabetic kidney disease.What was this study about?
The purpose of this study was to find out whether 3 different doses of a medicine called BI 685509 helps people with diabetic kidney disease. Diabetic kidney disease is a type of damage to the kidneys in some people with diabetes. Kidney disease means that the kidneys do not work properly. This results in symptoms like swelling, tiredness, difficulty sleeping, feeling sick or headaches.Who took part in this study?
People could take part in this study if they
• were aged 18 years or older
• had type 1 or 2 diabetes
• were diagnosed with diabetic kidney disease
243 people took part in this study. There were 184 men and 59 women. The youngest participant was 39 years old, and the oldest participant was 85 years old. The average age was 66 years.How was this study done?
The participants were divided into 3 groups randomly. Every participant had an equal chance of being in each group. No one could choose which group a participant was placed in, because it was done by a computer. All participants took BI 685509 or placebo as tablets 3 times a day. The groups were:
• Low dose group: participants took 1 mg of BI 685509 or placebo for 20 weeks
• Medium dose group: participants first took 1 mg of BI 685509 or placebo for 2 weeks; then, the participants took 2 mg of BI 685509 or placebo for another 18 weeks
• High dose group: participants first took 1 mg of BI 685509 or placebo for 2 weeks; then, the participants took 2 mg of BI 685509 or placebo for another 2 weeks; and after, the participants took 3 mg of BI 685509 or placebo for 16 weeks
The participants and doctors did not know whether the participants were in the BI 685509 groups or in the placebo group. This is because knowing which treatment a participant gets might affect the results of the study. At the end of the study, researchers learned which treatment each participant took.
In each group, participants had a 3 times higher chance to get BI 685509 than placebo. Placebo tablets looked like BI 685509 but did not contain any medicine. We compared BI 685509 with placebo to find out how well BI 685509 works.
Participants were in the study for about 7 months.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
The highest dose of BI 685509 showed an improvement in kidney function in people with diabetic kidney disease after 20 weeks of treatment.
We did statistical tests on the results. We found that it was unlikely that the difference between the treatment groups was due to chance.Did participants have any unwanted effects?
Yes, participants in both the placebo and medicine groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicine(s). In this study, 33 out of 241 participants (14%) had unwanted effects.
10 out of 61 participants (16%) were in the BI 685509 low dose group, 8 out of 61 participants (13%) were in the BI 685509 medium dose group, 9 out of 61 participants (15%) were in the BI 685509 high dose group. 6 out of 58 participants (10%) were in the placebo group.
The listing below shows the most common unwanted effects in the BI 685509 and placebo groups. The listing also shows how many participants in each group had each of these unwanted effects.
Low blood pressure (hypotension):
• BI 685509 high dose (61 participants): 4 participants
• BI 685509 medium dose (61 participants): 3 participants
• BI 685509 low dose (61 participants): 2 participants
• Placebo (58 participants): 0 participants
Swelling of the ankles, feet or hands (peripheral swelling):
• BI 685509 high dose (61 participants): 1 participant
• BI 685509 medium dose (61 participants): 1 participant
• BI 685509 low dose (61 participants): 0 participants
• Placebo (58 participants): 1 participant
Itchy skin (pruritus):
• BI 685509 high dose (61 participants): 1 participant
• BI 685509 medium dose (61 participants): 0 participants
• BI 685509 low dose (61 participants): 1 participant
• Placebo (58 participants): 0 participants
Difficulty to pass stool (constipation):
• BI 685509 high dose (61 participants): 1 participant
• BI 685509 medium dose (61 participants): 0 participants
• BI 685509 low dose (61 participants): 0 participants
• Placebo (58 participants): 1 participant
Nausea:
• BI 685509 high dose (61 participants): 0 participants
• BI 685509 medium dose (61 participants): 1 participant
• BI 685509 low dose (61 participants): 0 participants
• Placebo (58 participants): 1 participant
Diarrhoea:
• BI 685509 high dose (61 participants): 0 participants
• BI 685509 medium dose (61 participants): 0 participants
• BI 685509 low dose (61 participants): 2 participants
• Placebo (58 participants): 0 participants
Some unwanted effects in this study were serious because they required a stay in hospital or a longer stay in hospital, were life-threatening or fatal. Unwanted effects were also serious if the doctor thought they were serious for any other reason. In this study, 1 participant had a serious unwanted effect. 1 participant died from unwanted effects.Where did the study take place?
In this study, a total of 243 participants from 16 countries participated.
The following listing shows the regions and countries with the number of participants.
Europe (53): Denmark (6), Netherlands (2), Poland (4), Portugal (5), United Kingdom (5), Spain (31)
North America (82): Canada (8), Mexico (10), United States (64)
South America (41): Argentina (41)
Asia (59): China (8), Hong Kong (11), Japan (31), Malaysia (9)
Australia (8): Australia (7), New Zealand (1)
The total number of participants in the European Union was 48.Is there more information about this study?
You can find further information about this study at these websites:
1. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7C584215f43a794d483bd708dc191088db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638412805999307235%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ZG6zZzy4APwGm93%2B0fjj%2FGL6qxTKJI6T9wkJOmRij4A%3D&reserved=0 and search for the EudraCT number 2020-002929-28.
2. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7C584215f43a794d483bd708dc191088db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638412805999307235%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=UtMVshpphyh%2BDUaGFuI7NFlCXBcyNqdQmnR6GRAr3C0%3D&reserved=0 and search for the NCT number NCT04750577.
Boehringer Ingelheim sponsored this study. For contact details, please visit https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7C584215f43a794d483bd708dc191088db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638412805999307235%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Us4i4oU6pNE%2BfAFu85FvhtTdRSAZRRIVctp99agrH%2BQ%3D&reserved=0.
The full title of the study is: Randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease
This was a Phase II study. This study started in May 2021 and finished in Dec 2022.Are there additional studies?
If we do more clinical studies with BI 685509, you will find them on the websites listed above. To search for these studies, use the words BI 685509.Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2023 Boehringer Ingelheim International GmbH.REC name
London - South East Research Ethics Committee
REC reference
21/LO/0193
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion