[Translation] An open-label, single-center tolerability and pharmacokinetic study of recombinant human parathyroid hormone (1-84) for injection in healthy subjects

1.评价健康人对注射用重组人甲状旁腺素（1-84）单次给药和多次给药的安全性和耐受性； 2.观察注射用重组人甲状旁腺素（1-84）单次给药和多次给药后，健康人体内的药代动力学特征。

[Translation]

1. To evaluate the safety and tolerability of single and multiple doses of recombinant human parathyroid hormone (1-84) for injection in healthy subjects; 2. To observe the pharmacokinetic characteristics of recombinant human parathyroid hormone (1-84) for injection in healthy subjects after single and multiple doses.

Start Date16 Apr 2018

Sponsor / Collaborator

Chongqing Kerun Biopharm R&D Co., Ltd.

CTR20160847 / CompletedPhase 3

注射用重组人甲状旁腺素（1-84）治疗绝经后妇女骨质疏松的随机、开放、阳性药对照、多中心临床研究

[Translation] A randomized, open, positive-controlled, multicenter clinical study of recombinant human parathyroid hormone (1-84) for injection in the treatment of osteoporosis in postmenopausal women

进一步验证注射用重组人甲状旁腺素（1-84）治疗绝经后妇女骨质疏松的安全性和有效性

[Translation]

To further verify the safety and efficacy of recombinant human parathyroid hormone (1-84) for injection in the treatment of osteoporosis in postmenopausal women

Start Date14 Nov 2016

Sponsor / Collaborator

Chongqing Kerun Biopharm R&D Co., Ltd.

JPRN-UMIN000014074 / RecruitingNot ApplicableIIT

The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH) - The effect of improving the bone density at the surrounding TKA by PTH

Start Date04 Apr 2014

Sponsor / Collaborator-

100 Clinical Results associated with Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd)

100 Translational Medicine associated with Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd)

100 Patents (Medical) associated with Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd)

124

Literatures (Medical) associated with Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd)

01 Mar 2024·Endocrine Practice

Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism

Article

Author: Yin, Shaoming ; Ayodele, Olulade ; Tokareva, Elena ; Cusano, Natalie ; Finkelman, Richard D ; Rubin, Mishaela R

OBJECTIVERecombinant human parathyroid hormone (1-84) (rhPTH[1-84]) is efficacious in patients with hypoparathyroidism but additional data supporting its prolonged use are needed. We evaluated whether efficacy, safety, and tolerability are maintained during long-term rhPTH(1-84) treatment of patients with chronic hypoparathyroidism.METHODSThis was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614). Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters. Albumin-adjusted serum calcium levels (primary outcome measure), other disease biomarkers, health-related quality of life, and safety of rhPTH(1-84) were assessed using descriptive statistics.RESULTSAll patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study. Mean patient age was 51.9 years, 79.5% were female, and 97.4% were White. Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment. Mean doses of supplemental calcium and active vitamin D were maintained throughout the study. Bone turnover marker levels were maintained from baseline to end of treatment. No clinically relevant changes in bone mineral density were observed. Patient-reported health-related quality-of-life scores were generally maintained throughout the study. Four adverse events were considered treatment related and no new safety signals were identified.CONCLUSIONThe effects of rhPTH(1-84) on biochemical, skeletal, and health-related quality-of-life parameters did not wane with extended use.

01 Mar 2024·JBMR Plus

Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1–84) in hypoparathyroidism

Author: Abbott, Lisa G ; Rejnmark, Lars ; Yin, Shaoming ; Khan, Aliya A ; Finkelman, Richard D ; Takacs, Istvan ; Gagnon, Claudia ; Ing, Steven W ; Ahmed, Intekhab ; Ayodele, Olulade ; Mezosi, Emese

Abstract Hypoparathyroidism (HypoPT) is a rare disease, often inadequately controlled by conventional treatment. PARALLAX was a mandatory post-marketing trial assessing pharmacokinetics and pharmacodynamics of different dosing regimens of recombinant human parathyroid hormone 1–84 (rhPTH[1–84]) for treating HypoPT. The present study (NCT03364738) was a phase 4, 1-yr open-label extension of PARALLAX. Patients received only 2 doses of rhPTH(1–84) in PARALLAX and were considered treatment-naive at the start of the current study. rhPTH(1–84) was initiated at 50 μg once daily, with doses adjusted based on albumin-corrected serum calcium levels. Albumin-corrected serum calcium (primary outcome measure), health-related quality of life (HRQoL), adverse events, and healthcare resource utilization (HCRU) were assessed. The mean age of the 22 patients included was 50.0 yr; 81.8% were women, and 90.9% were White. By the end of treatment (EOT), 95.5% of patients had albumin-corrected serum calcium values in the protocol-defined range of 1.88 mmol/L to the upper limit of normal. Serum phosphorus was within the healthy range, and albumin-corrected serum calcium-phosphorus product was below the upper healthy limit throughout, while mean 24-h urine calcium excretion decreased from baseline to EOT. Mean supplemental doses of calcium and active vitamin D were reduced from baseline to EOT (2402–855 mg/d and 0.8–0.2 μg/d, respectively). Mean serum bone turnover markers, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and type I collagen C-telopeptide increased 2–5 fold from baseline to EOT. The HCRU, disease-related symptoms and impact on HRQoL improved numerically between baseline and EOT. Nine patients (40.9%) experienced treatment-related adverse events; no deaths were reported. Treatment with rhPTH(1–84) once daily for 1 yr improved HRQoL, maintained eucalcemia in 95% of patients, normalized serum phosphorus, and decreased urine calcium excretion. The effects observed on urine calcium and the safety profile are consistent with previous findings.Clinical trial identifierNCT03364738.

01 Apr 2023·Clinical Endocrinology

The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1‐84): A retrospective cohort study

Article

Author: Gosmanova, Elvira O. ; Ayodele, Olulade ; Lax, Angela ; Mu, Fan ; Swallow, Elyse ; Rejnmark, Lars

AbstractObjectiveThis 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).DesignRetrospective 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.PatientsOne hundred and eighteen patients treated with rhPTH(1‐84) and 497 patient controls.MeasurementsIncident 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.ResultsOver 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.ConclusionsPatients 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).

100 Deals associated with Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hypoparathyroidism	Phase 3	DK	Shire Plc	03 Apr 2017
Hypoparathyroidism	Phase 3	HU	Shire Plc	03 Apr 2017
Hypoparathyroidism	Phase 3	CA	Shire Plc	03 Apr 2017
Hypoparathyroidism	Phase 3	US	Shire Plc	03 Apr 2017
Osteoporosis, Postmenopausal	Phase 3	CN	Chongqing Kerun Biopharm R&D Co., Ltd.	14 Nov 2016

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