Sustained Improvement in Kidney Function with Palopegteriparatide in Adults with Chronic Hypoparathyroidism: Three-Year Results from the PaTH Forward and PaTHway Trials
Bibliographic record
Abstract
Background: Palopegteriparatide is a prodrug of PTH (1-34), administered once daily, designed to provide active PTH within the physiological range for 24 hours/day in adults for the treatment of chronic hypoparathyroidism. Conventional therapy for hypoparathyroidism (active vitamin D and calcium) is associated with hypercalciuria and an increased risk of CKD in these individuals. Rapid improvement in renal function after palopegteriparatide treatment initiation has been reported previously; this analysis evaluated the long-term impact of palopegteriparatide on renal function. Methods: Three-year data were analyzed post-hoc from the phase 2 PaTH Forward and phase 3 PaTHway trials, comprising randomized, double-blind, placebo-controlled periods through Weeks 4 and 26 and open-label extension periods through Weeks 266 and 182, respectively. Renal function was assessed by eGFR. eGFR ≥30 mL/min/1.73 m2 was required for eligibility. Safety assessments included 24-hour urine calcium excretion and treatment-emergent adverse events (TEAEs). Results: At Year 3, ≥91% of participants receiving palopegteriparatide in both trials were independent from conventional therapy (no active vitamin D and ≤600 mg/day elemental calcium) and ≥84% had normocalcemia (8.3-10.6 mg/dL). Mean (SD) eGFR increased from baseline to Year 3 by 9.8 (10.9) mL/min/1.73 m2 in PaTH Forward and by 8.8 (11.9) mL/min/1.73 m2 in PaTHway. eGFR slope had an initial increase from baseline to 26 weeks (12.5 and 15.6 mL/min/1.73m2/year, annualized) followed by chronic slope stabilization from week 26 to Year 3 (0.6 and 1.2 mL/min/1.73 m2/year). Mean 24-hour urine calcium levels normalized (≤250 mg/day), decreasing from baseline to Year 3 (428.0 to 174.4 mg/day, PaTH Forward; 375.6 to 162.1 mg/day, PaTHway). Most TEAEs were grade 1 or 2, with no new safety signals identified. Conclusion: Palopegteriparatide treatment showed sustained improvement in renal function, resolution of hypercalciuria, and continued safety and efficacy through Year 3 of PaTH Forward and PaTHway. Funding: Commercial Support - Ascendis Pharma Bone Diseases A/S
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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) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".