NCT06322056Recruiting
Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 642 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 13 May 2024
- Primary completion date
- 31 May 2029
- Lead sponsor
- Yonsei University
- NCT number
- NCT06322056
What you commit to
- Study type: Interventional
- Planned participants: 642
- From 13 May 2024 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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 of screening visit
- 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%
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.