FP633A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PHASE 2B STUDY TO ASSESS THE EFFECT OF SNF472 ADDED TO STANDARD OF CARE ON PROGRESSION OF CARDIOVASCULAR CALCIFICATION IN PATIENTS WITH END-STAGE RENAL DISEASE ON MAINTENANCE HAEMODIALYSIS (CaLIPSO STUDY)
Bibliographic record
Abstract
INTRODUCTION: Chronic kidney disease (CKD) is associated with substantial morbidity, premature mortality, and decreased health-related quality of life. As kidney function declines, a variety of metabolic and hormonal abnormalities accumulate, eventually leading to a chronic state of inflammation, malnutrition and disordered mineral metabolism. These conditions promote calcium deposition in the vasculature and contribute to the burden of cardiovascular disease (CVD) in CKD. A large body of evidence suggests that cardiovascular calcification plays an important role in the clinical manifestation of CVD in CKD and particularly in end-stage renal disease. SNF472, an intravenous formulation of myo-inositol hexaphosphate, selectively inhibits the formation and growth of hydroxyapatite crystals, the final common pathway in the etiology of vascular calcification. The objective of this study is to assess the effect of SNF472 on progression of coronary artery calcium (CAC) volume score over 52 weeks in patients on haemodialysis (HD). METHODS: CaLIPSO is a multinational, randomised, double-blind, placebo-controlled phase 2b trial to assess the effect of two doses of SNF472 on progression of CAC. Adult patients on maintenance HD (≥6 months) with CAC/Agatston score of 100 to 3500 AU and either ≥55 years or with a history of diabetes mellitus were stratified by CAC Agatston score (100-399, 400-1000 and >1000) and randomized in a 1:1:1 ratio to 300 mg SNF472, 600 mg SNF472 or placebo. SNF472 or placebo is administered during each dialysis session (3 times per week). CAC scores are obtained by multi-detector CT scanner at screening and Week 52. The primary endpoint is the change in log CAC volume score between baseline and Week 52. Key secondary endpoints are number of patients with <15% progression in CAC/Agatston score at Week 52 and change from baseline in aorta calcification score and aortic valve calcification score at Week 52. RESULTS: 274 patients were randomized to SNF472 or placebo. Mean age 63.6 years, 61% men, 69% white, and median dialysis vintage 42.4 months. Baseline mean CAC/Agatston score was 946.4 (range 102, 3429). The table shows selected medical history and medication use at baseline. Age and history of coronary artery disease were significant predictors of CAC at baseline, while diabetes mellitus was of borderline significance (p=0.059). CONCLUSIONS: The CaLIPSO study will evaluate the effect of SNF472 on progression of cardiovascular calcification in patients on maintenance HD.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".