BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06322056
What this study is testing
What is Intensive control of SBP and intensive control of LDL-C?
Intensive control of SBP and intensive control of LDL-C is an investigational medicine, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Fulfillment of all of followings
- At least 19 years old
- Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to \<45 mL/min/1.73 m2
- SBP of
- 130-180 mmHg on 0 or 1 medication
You likely can't join if
- Any of followings
- Resistant hypertension or poorly controlled hypertension
- Failure to achieve SBP of \<140 mmHg despite using 4 or more antihypertensive medications including diuretics
- Known secondary cause of hypertension
- History of renal devervation procedure
- Glomerulonephritis requiring immunosuppresive agents
See the full eligibility criteria
- Fulfillment of all of followings
- At least 19 years old
- Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to \<45 mL/min/1.73 m2
- SBP of
- 130-180 mmHg on 0 or 1 medication
- 130-170 mmHg on upto 2 medications
- 130-160 mmHg on more than 3 medications
- LDL-C ≥100 mg/dL
- Any of followings
- Resistant hypertension or poorly controlled hypertension
- Failure to achieve SBP of \<140 mmHg despite using 4 or more antihypertensive medications including diuretics
- Known secondary cause of hypertension
- History of renal devervation procedure
- Glomerulonephritis requiring immunosuppresive agents
- Autosomal dominant polycystic kidney disease receiving tolvaptan
- CKD-EPI \< 15 mL/min/1.73 m2 or receiving kidney replacement therapy
- Familial hypercholesterolemia
- Cardiovascular event or precedure (as defined as myocardial infarction, unstable angina, coronary revascularization, or stroke) within last 3 months or planning to cardiovascular procedure upcoming 3 months at the time...
- Symptomatic heart failure within 6 months of left ventricular ejection fraction \<45%
- A medical condition likely to limit survival to less thant 3 years
- Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
- Any organ transplant
- Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
- Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
- History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
- Using any drugs as followings:
- Nicotinic acid
- Macrolide antibiotics
- Systemic imidazole or triazole antifungal agent
- Protease inhibitor
- Nefazodone
- Immunosuppressive agents (glucocorticoid [equivalent to prednisone 10 mg/day over 4 weeks], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab)
- Pregnancy or trying to become pregnant
- Diabetes mellitus, type I
- Diabetes mellitus, type II with HbA1c ≥10.0%
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.