The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) : A retrospective cohort study
© 2022 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd..
OBJECTIVE: This study assessed the risk of developing chronic kidney disease (CKD) and decline in estimated glomerular filtration rate (eGFR) over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) compared with a historical control cohort of patients not treated with rhPTH(1-84).
DESIGN: Retrospective cohort study of patients with chronic hypoparathyroidism treated with rhPTH(1-84) derived from the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) and HEXT (NCT01199614, and its continuation study NCT02910466) clinical trials and a historical control cohort who did not receive PTH selected from an electronic medical record database.
PATIENTS: One hundred and eighteen patients treated with rhPTH(1-84) and 497 patient controls.
MEASUREMENTS: Incident CKD was defined as ≥2 eGFR measurements <60 ml/min/1.73 m2 ≥3 months apart during the study and a sustained eGFR decline of ≥30% from baseline.
RESULTS: Over the 5-year period, Kaplan-Meier analyses showed that rhPTH(1-84)-treated patients had a significantly lower risk of developing CKD (log-rank p = .002) and a lower risk for a sustained eGFR decline ≥30% from baseline (log-rank p < .001) compared with patients in the control cohort. In adjusted analyses, patients in the rhPTH(1-84)-treated cohort had a 53% lower risk of developing CKD (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.25-0.87) and a 65% lower risk for sustained eGFR decline ≥30% from baseline (HR, 0.35; 95% CI, 0.13-0.89) compared with controls.
CONCLUSIONS: Patients with chronic hypoparathyroidism treated with rhPTH(1-84) in long-term clinical trials had a significantly lower risk of developing CKD compared with patients in a historical control cohort not treated with rhPTH(1-84).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:98 |
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| Enthalten in: |
Clinical endocrinology - 98(2023), 4 vom: 17. Apr., Seite 496-504 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rejnmark, Lars [VerfasserIn] |
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| Links: |
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| Themen: |
Chronic kidney disease |
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| Anmerkungen: |
Date Completed 14.03.2023 Date Revised 30.04.2023 published: Print-Electronic ClinicalTrials.gov: NCT01297309, NCT00732615, NCT01268098, NCT02910466 Citation Status MEDLINE |
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| doi: |
10.1111/cen.14813 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM344930769 |
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| 100 | 1 | |a Rejnmark, Lars |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) |b A retrospective cohort study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Revised 30.04.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01297309, NCT00732615, NCT01268098, NCT02910466 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd. | ||
| 520 | |a OBJECTIVE: This study assessed the risk of developing chronic kidney disease (CKD) and decline in estimated glomerular filtration rate (eGFR) over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) compared with a historical control cohort of patients not treated with rhPTH(1-84) | ||
| 520 | |a DESIGN: Retrospective cohort study of patients with chronic hypoparathyroidism treated with rhPTH(1-84) derived from the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) and HEXT (NCT01199614, and its continuation study NCT02910466) clinical trials and a historical control cohort who did not receive PTH selected from an electronic medical record database | ||
| 520 | |a PATIENTS: One hundred and eighteen patients treated with rhPTH(1-84) and 497 patient controls | ||
| 520 | |a MEASUREMENTS: Incident CKD was defined as ≥2 eGFR measurements <60 ml/min/1.73 m2 ≥3 months apart during the study and a sustained eGFR decline of ≥30% from baseline | ||
| 520 | |a RESULTS: Over the 5-year period, Kaplan-Meier analyses showed that rhPTH(1-84)-treated patients had a significantly lower risk of developing CKD (log-rank p = .002) and a lower risk for a sustained eGFR decline ≥30% from baseline (log-rank p < .001) compared with patients in the control cohort. In adjusted analyses, patients in the rhPTH(1-84)-treated cohort had a 53% lower risk of developing CKD (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.25-0.87) and a 65% lower risk for sustained eGFR decline ≥30% from baseline (HR, 0.35; 95% CI, 0.13-0.89) compared with controls | ||
| 520 | |a CONCLUSIONS: Patients with chronic hypoparathyroidism treated with rhPTH(1-84) in long-term clinical trials had a significantly lower risk of developing CKD compared with patients in a historical control cohort not treated with rhPTH(1-84) | ||
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| 700 | 1 | |a Swallow, Elyse |e verfasserin |4 aut | |
| 700 | 1 | |a Gosmanova, Elvira O |e verfasserin |4 aut | |
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