Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway-trial
Authors' conclusion
These findings demonstrate sustained renal safety of palopegteriparatide and suggest that PTH replacement therapy with palopegteriparatide preserves and may improve renal function in adults with chronic hypoparathyroidism after 104 wk of treatment.
Study context
- Population
- Adults with chronic hypoparathyroidism76 remained at Week 104
- Participants
- 82 adults
- Primary endpoint
- Change in renal function assessed using eGFR
- Follow-up
- Week 104
Methodological detailsopen-label extension
- Open-label extension
Primary result
As reported in the abstract
| Group | Value | Mean (SD) change from baseline | P | Estimated glomerular filtration rate (eGFR) increase ≥5 mL/min/1.73 m² | eGFR increase ≥10 mL/min/1.73 m² |
|---|---|---|---|---|---|
| Palopegteriparatide | mean 77.8 (SD 14.8) mL/min/1.73 m² | 9.0 (10.3) mL/min/1.73 m² | p < .0001 | 45% | 34% |
Palopegteriparatide
Further findings
Change in eGFR from baseline · Week 52
- Mean (SD) increase in eGFR from baseline, mL/min/1.73m2
- 8.9 (11.0)
- P
- P < 0.0001
- Post hoc analysis
Increase in eGFR ≥5 and ≥10 mL/min/1.73 m² · Week 104
- Increase in eGFR ≥5 mL/min/1.73 m²
- 45%
- Increase in eGFR ≥10 mL/min/1.73 m²
- 34%
Albumin-adjusted serum calcium in normal range (8.3-10.6 mg/dL) · Week 104
- Participants remaining in open-label extension with normal albumin-adjusted serum calcium
- 82%
Independence from conventional therapy (≤600 mg/d elemental calcium and no active vitamin D) · Week 104
- Participants remaining in open-label extension independent from conventional therapy
- 97%
Serum phosphate and albumin-adjusted calcium × phosphate product · Week 104
- Mean (SD) serum phosphate, mg/dL (within normal range)
- 3.5 (0.7)
- Mean (SD) albumin-adjusted calcium × phosphate product, mg2/dL2 (within normal range)
- 30.7(5.1)
24-h urine calcium · Week 104
- Normalized within 26 wk and maintained below 250 mg/d through Week 104; mean (SD), mg/24 h
- 158.8 (90.5)
Safety
Treatment-emergent adverse events · Week 104
- Most treatment-emergent adverse events were mild or moderate
- No new safety signals or cases of treatment-related nephrolithiasis reported
Original publication
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