| Trial ID: | L1672 |
| Source ID: | NCT05004363
|
| Associated Drug: |
Lokelma Oral Product
|
| Title: |
Lokelma for RAAS Maximisation in CKD & Heart Failure.
|
| Acronym: |
LIFT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Heart Failure With Reduced Ejection Fraction|Hyperkalemia|ACE Inhibitor Induced Hyperkalaemia|Mineralocorticoid Resistant Hyperkalemia
|
| Interventions: |
DRUG: Lokelma Oral Product
|
| Outcome Measures: |
Primary: Number of participants who achieve the maximum dose, Ramipril 5 mg OD + Spironolactone 25 mg OD for patients on a baseline RAASi dose that is less than Ramipril 5 mg OD + Spironolactone 25 mg OD or equivalent Ramipril 10 mg OD + Spironolactone 50 mg OD for patients on a baseline RAASi dose that is more or equal than Ramipril 5 mg OD + Spironolactone 25 mg OD or equivalent, 16 weeks | Secondary: Number of participants achieving other outcomes, 1. Achieving maximum dose of Mineralocorticoid receptor antagonists (MRA) and Angiotension-converting enzyme (ACEi) / Angiotensin-receptor blockers (ARB) and K+\<5.6 mmol/L 2. Achieving maximum dose of MRA and ACEi/ARB and K+≤6.0 mmol/L 3. Time since randomisation to first occurrence of hyperkalaemia (K+\>5.5 mmol/L) 4. Time since randomisation to severe hyperkalaemia (K+\>6.0) 5. Number of ACEi/ARB, MRA end of study as compared to baseline 6. Number of hospital admissions and duration of hospital admissions during the study 7. Change in serum potassium at the respective visits as compared to baseline, 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: St George's, University of London
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
130
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-01-19
|
| Completion Date: |
2023-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-18
|
| Locations: |
St Georges, University of London, London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05004363
|
