Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600412
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of the ABCA1 Inducer R3R01 on Albuminuria Levels in Diabetic Kidney Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Kidney ABC
Brief Summary:
The goal of this clinical trial is to to investigate whether the drug R3R01 has a beneficial effect on the amount of protein excreted in the urine in adult patients above 18 years of age with type 2 diabetes and resulting kidney disease
The main questions it aims to answer are
1 Does 3 months of treatment with 200mg of the drug R3R01 morning and evening have a beneficial effect on the amount of protein excreted in the urine in patients with type 2 diabetes and kidney disease
2 Does R3R01 have an effect on kidney function and daily blood pressure
Researchers will compare the results of 40 people who take R3R01 to 20 people who receive an inactive substance placebo
Participants will receive R3R01 or the placebo as an oral tablet and undergo a selection of medical examinations - such as
blood samples
urine tests
kidney tests involving a radiolabelled marker which is injected into the bloodstream and monitored via blood samples
24 hour blood pressure monitoring via a wearable device
urine pregnancy test if applicable
The main questions it aims to answer are
1 Does 3 months of treatment with 200mg of the drug R3R01 morning and evening have a beneficial effect on the amount of protein excreted in the urine in patients with type 2 diabetes and kidney disease
2 Does R3R01 have an effect on kidney function and daily blood pressure
Researchers will compare the results of 40 people who take R3R01 to 20 people who receive an inactive substance placebo
Participants will receive R3R01 or the placebo as an oral tablet and undergo a selection of medical examinations - such as
blood samples
urine tests
kidney tests involving a radiolabelled marker which is injected into the bloodstream and monitored via blood samples
24 hour blood pressure monitoring via a wearable device
urine pregnancy test if applicable
Detailed Description:
An increasing amount of evidence suggests that lipid dysmetabolism and accumulation in the kidneys play a central role in the pathogenesis of kidney disease This lipotoxicity in turn may contribute to the development of albuminuria and chronic kidney disease
One may surmise that interventions that reduce or prevent the progression of kidney lipid accumulation protect against the progression of kidney disease including diabetic kidney disease DKD Therefore it is possible inhibiting cholesterol absorption might effectively protect against lipid accumulation and related disease in the kidneys
R3R01 is an ATP-binding cassette transporter A1 ABCA1 inducer which increases the efflux of cholesterol from the intracellular space in the kidney
Persons with type 2 diabetes with moderate and severe albuminuria have a poor renal and cardiovascular prognosis As albuminuria is viewed both as a risk marker but also as a target for intervention any treatment with antiproteinuric effects could be beneficial The role of ABCA1 inducer treatment on kidney parameters in diabetic kidney disease is not known By investigating the impact of ABCA1 inducer treatment on albuminuria it will be determined whether this intervention may represent a future treatment option
This study is a single center double-blind placebo controlled parallel group randomized 21 study in 60 people with type 2 diabetes with moderate or severe albuminuria and estimated glomerular filtration rate eGFR above 30 mlmin173m2 40 people will take R3R01 whilst 20 people receive the placebo
The studys primary objective is to evaluate the effect of 12 weeks treatment with R3R01 on albuminuria in the study population In addition to a 12 week treatment period there will be a follow-up period of approximately 12 weeks 84 days The expected total duration of study participation is up to 24 weeks for each patient
One may surmise that interventions that reduce or prevent the progression of kidney lipid accumulation protect against the progression of kidney disease including diabetic kidney disease DKD Therefore it is possible inhibiting cholesterol absorption might effectively protect against lipid accumulation and related disease in the kidneys
R3R01 is an ATP-binding cassette transporter A1 ABCA1 inducer which increases the efflux of cholesterol from the intracellular space in the kidney
Persons with type 2 diabetes with moderate and severe albuminuria have a poor renal and cardiovascular prognosis As albuminuria is viewed both as a risk marker but also as a target for intervention any treatment with antiproteinuric effects could be beneficial The role of ABCA1 inducer treatment on kidney parameters in diabetic kidney disease is not known By investigating the impact of ABCA1 inducer treatment on albuminuria it will be determined whether this intervention may represent a future treatment option
This study is a single center double-blind placebo controlled parallel group randomized 21 study in 60 people with type 2 diabetes with moderate or severe albuminuria and estimated glomerular filtration rate eGFR above 30 mlmin173m2 40 people will take R3R01 whilst 20 people receive the placebo
The studys primary objective is to evaluate the effect of 12 weeks treatment with R3R01 on albuminuria in the study population In addition to a 12 week treatment period there will be a follow-up period of approximately 12 weeks 84 days The expected total duration of study participation is up to 24 weeks for each patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None