Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway-trial.

Rejnmark L, Gosmanova EO, Khan AA, Sprague S, Shoback DM, Kohlmeier L, Rubin MR, Palermo A, Schwarz P, Gagnon C, Tsourdi E, Takeuchi Y and 11 more

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Makita N, Imanishi Y, Gittoes N, Díez JJ, Prot-Bertoye C, Lai B, Zhao C, Ukena J, Makara MA, Sibley CT, Shu AD

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Aug 2026Cited by 3 (Europe PMC)

PMID42166177PMCIDPMC13525197DOI10.1093/jbmr/zjag085PepBankPUB-42166177

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Summary

The PaTHway clinical trial demonstrated sustained efficacy, safety, and tolerability of daily palopegteriparatide in the treatment of adults with hypoparathyroidism. Palopegteriparatide treatment was also associated with improvements in estimated glomerular filtration rate (eGFR) over 52 wk in a post hoc analysis, prompting further exploration of palopegteriparatide in the preservation of renal function. The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR. At Week 104, 93% (76/82) of participants remained in the open-label extension. Of those, 82% had albumin-adjusted serum calcium levels in the normal range (8.3-10.6 mg/dL), 97% were independent from conventional therapy (≤600 mg/d of elemental calcium and no active vitamin D). Mean (SD) serum phosphate (3.5 (0.7) mg/dL) and albumin-adjusted calcium × phosphate product (30.7(5.1) mg2/dL2) levels were also within normal ranges. Palopegteriparatide treatment resulted in a mean (SD) increase in eGFR of 8.9 (11.0) mL/min/1.73m2 (p < .0001) from baseline to Week 52, which was sustained through Week 104, where it was 77.8 (14.8) mL/min/1.73 m2 with a mean (SD) change from baseline of 9.0 (10.3) mL/min/1.73 m2 (p < .0001). By Week 104, 45% and 34% of participants had an increase in eGFR of ≥5 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2, respectively. Palopegteriparatide treatment normalized mean (SD) 24-h urine calcium within 26 wk and maintained levels below 250 mg/d through Week 104 (158.8 (90.5) mg/24 h). Most treatment-emergent adverse events were mild or moderate; no new safety signals or cases of treatment-related nephrolithiasis were reported. 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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanNon-randomized trialEfficacy outcome
At Week 104, 93% (76/82) of participants remained in the palopegteriparatide open-label extension.
In plain wordsAt Week 104, 93% of participants remained in the palopegteriparatide extension.
Peptide
Palopegteriparatide
Outcome
Not applicableExtension retention at week 104
Study
n = 82
Outcome group
Treatment adherence and retention · Whole body
Studied dose
Dose not stated
Measurements
Retention
93%
Week 104
Retained participants
76 participants
of 82
Source sentences
Summary
At Week 104, 93% (76/82) of participants remained in the open-label extension.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617701
02HumanNon-randomized trialEfficacy outcome
At Week 104, 82% of retained participants receiving palopegteriparatide had normal albumin-adjusted serum calcium.
In plain wordsAt Week 104, 82% of retained participants receiving palopegteriparatide had normal blood calcium.
Peptide
Palopegteriparatide
Outcome
Not applicableNormal serum calcium at week 104
Study
n = 76
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Normal serum calcium
82%
retained participants
Normal calcium reference range
8.3 to 10.6 mg/dL
albumin-adjusted serum calcium
Source sentences
Summary
Of those, 82% had albumin-adjusted serum calcium levels in the normal range (8.3-10.6 mg/dL), 97% were independent from conventional therapy (≤600 mg/d of elemental calcium and no active vitamin D).
2 context sentences(design, population, supporting numbers)
Summary · context
At Week 104, 93% (76/82) of participants remained in the open-label extension.
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617702
03HumanNon-randomized trialEfficacy outcome
At Week 104, 97% of retained palopegteriparatide participants needed no active vitamin D and ≤600 mg/d elemental calcium.
In plain wordsAt Week 104, 97% of retained palopegteriparatide participants needed no active vitamin D and ≤600 mg/d elemental calcium.
Peptide
Palopegteriparatide
Outcome
Not applicableIndependence from conventional therapy at week 104
Study
n = 76
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Independent participants
97%
Week 104
Elemental calcium allowance
≤ 600 mg/d
independence criterion
Source sentences
Summary
Of those, 82% had albumin-adjusted serum calcium levels in the normal range (8.3-10.6 mg/dL), 97% were independent from conventional therapy (≤600 mg/d of elemental calcium and no active vitamin D).
2 context sentences(design, population, supporting numbers)
Summary · context
At Week 104, 93% (76/82) of participants remained in the open-label extension.
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617703
04HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving palopegteriparatide, mean serum phosphate was normal at 3.5 (SD 0.7) mg/dL.
In plain wordsIn adults receiving palopegteriparatide, mean blood phosphate was within normal limits.
Peptide
Palopegteriparatide
Outcome
Not applicableSerum phosphate
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Mean serum phosphate
3.5 mg/dL
palopegteriparatide participants
SD
0.7 mg/dL
serum phosphate
Source sentences
Summary
Mean (SD) serum phosphate (3.5 (0.7) mg/dL) and albumin-adjusted calcium × phosphate product (30.7(5.1) mg2/dL2) levels were also within normal ranges.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617704
05HumanNon-randomized trialEfficacy outcome
In adults receiving palopegteriparatide, mean albumin-adjusted calcium × phosphate product was normal at 30.7 (SD 5.1) mg2/dL2.
In plain wordsIn adults receiving palopegteriparatide, the average calcium and phosphate product remained within normal limits.
Peptide
Palopegteriparatide
Outcome
Not applicableCalcium phosphate product
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Mean calcium phosphate product
30.7 mg2/dL2
palopegteriparatide participants
SD
5.1 mg2/dL2
calcium phosphate product
Source sentences
Summary
Mean (SD) serum phosphate (3.5 (0.7) mg/dL) and albumin-adjusted calcium × phosphate product (30.7(5.1) mg2/dL2) levels were also within normal ranges.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617705
06HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, palopegteriparatide increased mean eGFR by 8.9 (SD 11.0) mL/min/1.73m2 from baseline to Week 52.
In plain wordsIn adults with hypoparathyroidism, kidney filtration increased from baseline to Week 52 during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR change at week 52
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Mean eGFR change
8.9 mL/min/1.73m2
baseline to Week 52
SD
11 mL/min/1.73m2
eGFR change
P value
< 0.0001
baseline to Week 52
Source sentences
Summary
Palopegteriparatide treatment resulted in a mean (SD) increase in eGFR of 8.9 (11.0) mL/min/1.73m2 (p < .0001) from baseline to Week 52
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617706
07HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism receiving palopegteriparatide, mean eGFR at Week 104 was 77.8 (SD 14.8) mL/min/1.73 m2.
In plain wordsIn adults receiving palopegteriparatide, mean kidney filtration at Week 104 was 77.8 mL/min/1.73 m2.
Peptide
Palopegteriparatide
Outcome
Not applicableeGFR at week 104
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Mean eGFR
77.8 mL/min/1.73 m2
Week 104
SD
14.8 mL/min/1.73 m2
eGFR
Source sentences
Summary
which was sustained through Week 104, where it was 77.8 (14.8) mL/min/1.73 m2 with a mean (SD) change from baseline of 9.0 (10.3) mL/min/1.73 m2 (p < .0001).
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617707
08HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, mean eGFR increased by 9.0 (SD 10.3) mL/min/1.73 m2 from baseline to Week 104 during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, kidney filtration increased from baseline to Week 104 during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR change at week 104
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Mean eGFR change
9 mL/min/1.73 m2
baseline to Week 104
SD
10.3 mL/min/1.73 m2
eGFR change
P value
< 0.0001
baseline to Week 104
Source sentences
Summary
which was sustained through Week 104, where it was 77.8 (14.8) mL/min/1.73 m2 with a mean (SD) change from baseline of 9.0 (10.3) mL/min/1.73 m2 (p < .0001).
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617708
09HumanNon-randomized trialEfficacy outcome
By Week 104, 45% of palopegteriparatide participants had an eGFR increase of at least 5 mL/min/1.73 m2.
In plain wordsBy Week 104, 45% of palopegteriparatide participants had kidney filtration increases of at least 5 mL/min/1.73 m2.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR increase of at least 5
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Responders
45%
eGFR increase ≥5 mL/min/1.73 m2
Source sentences
Summary
By Week 104, 45% and 34% of participants had an increase in eGFR of ≥5 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617709
10HumanNon-randomized trialEfficacy outcome
By Week 104, 34% of palopegteriparatide participants had an eGFR increase of at least 10 mL/min/1.73 m2.
In plain wordsBy Week 104, 34% of palopegteriparatide participants had kidney filtration increases of at least 10 mL/min/1.73 m2.
Peptide
Palopegteriparatide
Outcome
IncreaseeGFR increase of at least 10
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Responders
34%
eGFR increase ≥10 mL/min/1.73 m2
Source sentences
Summary
By Week 104, 45% and 34% of participants had an increase in eGFR of ≥5 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617710
11HumanNon-randomized trialEfficacy outcome
In adults with hypoparathyroidism, palopegteriparatide normalized mean urine calcium within 26 wk and maintained levels below 250 mg/d through Week 104.
In plain wordsDuring palopegteriparatide treatment, mean urine calcium normalized within 26 wk and remained below 250 mg/d through Week 104.
Peptide
Palopegteriparatide
Outcome
DecreaseUrine calcium normalization
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Mean urine calcium
158.8 mg/24 h
Week 104
SD
90.5 mg/24 h
urine calcium
Urine calcium level maintained below
< 250 mg/d
through Week 104
Source sentences
Summary
Palopegteriparatide treatment normalized mean (SD) 24-h urine calcium within 26 wk and maintained levels below 250 mg/d through Week 104 (158.8 (90.5) mg/24 h).
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617711
12HumanNon-randomized trialSafety outcome
Most treatment-emergent adverse events during palopegteriparatide treatment in adults with hypoparathyroidism were mild or moderate.
In plain wordsMost adverse events during palopegteriparatide treatment were mild or moderate.
Peptide
Palopegteriparatide
Outcome
Not applicableTreatment-emergent adverse event severity
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Most treatment-emergent adverse events were mild or moderate; no new safety signals or cases of treatment-related nephrolithiasis were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617712
13HumanNon-randomized trialSafety outcome
No new safety signals were reported during palopegteriparatide treatment in adults with hypoparathyroidism.
In plain wordsNo new safety signals were reported during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableNew safety signals
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Most treatment-emergent adverse events were mild or moderate; no new safety signals or cases of treatment-related nephrolithiasis were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617713
14HumanNon-randomized trialSafety outcome
No treatment-related nephrolithiasis was reported during palopegteriparatide treatment in adults with hypoparathyroidism.
In plain wordsNo treatment-related kidney stones were reported during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableTreatment-related nephrolithiasis
Study
n: not reported in source
Outcome group
Adverse events · Kidney and urinary
Studied dose
Dose not stated
Source sentences
Summary
Most treatment-emergent adverse events were mild or moderate; no new safety signals or cases of treatment-related nephrolithiasis were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR.
Show in the study text Report a problemFND-4216617714

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway-trial.

Summary

Results from this study14

Version history

Subjects

Publication types

MeSH terms

Keywords