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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.002 | 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 source (direct Gemma or distilled Codex), 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".