PaTHway (post-hoc analysis)
Trial question
What is the effect of palopegteriparatide on renal function in adult patients with chronic hypoparathyroidism?
Study design
Multi-center
Double blinded
RCT
Population
78 patients
Inclusion criteria: adult patients with chronic hypoparathyroidism
Key exclusion criteria: pseudohypoparathyroidism or any disease that might affect calcium metabolism, calcium-phosphate homeostasis, or PTH levels other than hypoparathyroidism; pregnancy
Interventions
N=59 palopegteriparatide (at a dose of 18 mcg daily, further titrated individually to an optimal dose)
N=19 placebo (matching placebo)
Primary outcome
Mean change in estimaged glomerular filtration rate at week 26
7.9
-1.9
7.9 mL/min/1.73m²
5.9 mL/min/1.73m²
4.0 mL/min/1.73m²
2.0 mL/min/1.73m²
0.0 mL/min/1.73m²
-2.0 mL/min/1.73m²
Palopegteriparatide
Placebo
Significant
increase ▲
Significant increase in mean change in estimaged GFR at week 26 (7.9 mL/min/1.73 m² vs. -1.9 mL/min/1.73 m²; LSMD 8.8, 95% CI 3.73 to 13.87)
Secondary outcomes
Significant increase in mean change in estimaged GFR at week 52 (9.3 mL/min/1.73 m² vs. 7.6 mL/min/1.73 m²; AD 1.7 mL/min/1.73 m², 95% CI 0.85 to 2.55)
Safety outcomes
No significant differences in change in serum and 24-hour urine calcium, phosphate, and creatinine, and treatment-emergent adverse events.
Significant difference in serious adverse events (17% vs. 7%).
Conclusion
In adult patients with chronic hypoparathyroidism, palopegteriparatide was superior to placebo with respect to mean change in estimaged GFR at week 26.
Reference
Lars Rejnmark, Elvira O Gosmanova, Aliya A Khan et al. Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial. Adv Ther. 2024 Jun;41(6):2500-2518.
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