A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.

The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.

开始日期2022-04-13

申办/合作机构

华润昂德生物药业有限公司

100 项与重组人促红素 (华润昂德) 相关的临床结果

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100 项与重组人促红素 (华润昂德) 相关的转化医学

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100 项与重组人促红素 (华润昂德) 相关的专利（医药）

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项与重组人促红素 (华润昂德) 相关的文献（医药）

2022-01-01·Journal of Orthopaedic Science4区 · 医学

GDF15 enhances proliferation of aged chondrocytes by phosphorylating SMAD2

4区 · 医学

Article

作者: Wang, Dongming ; Geng, Xiang ; Wei, Xiaochun ; Li, Lu ; Li, Pengcui

BACKGROUNDAging is one of the primary factors influencing development of osteoarthritis, and the TGF-β pathway plays an important role in age-related osteoarthritis. Specifically, GDF15 phosphorylates SMAD2/3 in the TGF-β pathway to inhibit cardiomyocyte hypertrophy, and promote proliferation of chondrocytes. However, age-dependent changes in the level of GDF15 are unclear, as is whether GDF15 phosphorylates SMAD2/3 in the TGF-β pathway to promote proliferation of old chondrocytes. This study, therefore, sought to examine the effect of various GDF15 concentrations on old chondrocyte proliferation.METHODSSerum and cartilage specimens of young adults and older adults were collected, and GDF15 expression was quantified. Human chondrocytes were then cultured following routine protocols, and different concentrations of recombinant human GDF15 or pSMAD2 inhibitor were added into the culture medium. After 48 h of culturing, the proliferation of chondrocytes was detected by EdU, and the expression MMP13, SMAD2, and pSMAD2 was detected in chondrocytes via western blot and qRT-PCR analysis.RESULTSThe GDF15 content in serum and cartilage of young adults was higher than that of older adults (p < 0.05). The number of EdU-positive cells in the experimental group (containing recombinant human GDF15) was higher than that in the control group (medium only) (p < 0.05). Compared with the control group, chondrocytes in the experimental group showed increased pSMAD2 and type II collagen content (p < 0.05) and decreased MMP13 (p < 0.05), with no significant difference in SMAD2 content (p > 0.05). Moreover, no significant differences were observed between the control group and the TGF-β signaling inhibitor group. The gene expression level of each index was consistent with the protein expression level.CONCLUSIONSThe GDF15 content of serum and cartilage in young adults is higher than in older adults, and GDF15 functions to promote the proliferation of chondrocytes by phosphorylating SMAD2 in older individuals.

2021-12-01·Endocrinology and Metabolism Clinics of North America2区 · 医学

Drug-Related Hypercalcemia

2区 · 医学

Review

作者: Livrozet, Marine ; Blanchard, Anne ; Kamenický, Peter ; Lecoq, Anne-Lise

This review focuses on the commonly prescribed medicaments that can be responsible for hypercalcemia, considering the prevalence, the predominant pathophysiological mechanisms, and the optimal medical management of each drug-induced hypercalcemia. Vitamin D supplements and 1α-hydroxylated vitamin D analogues increase intestinal calcium absorption, renal calcium reabsorption as well as bone resorption. In patients with hypoparathyroidism receiving recombinant human PTH, transient hypercalcemia can occur because of overtreatment, usually during acute illness. Thiazide-induced hypercalcemia is mainly explained by enhanced renal proximal calcium reabsorption, changing preexistent asymptomatic normocalcemic or intermittently hypercalcemic hyperparathyroidism into the classic hypercalcemic hyperparathyroidism. Lithium causes hypercalcemia mainly by drug-induced hyperparathyroidism.

2016-11-01·Expert Opinion on Biological Therapy3区 · 医学

Natpara for the treatment of hypoparathyroidism

3区 · 医学

Article

作者: Della Pepa, Giuseppe ; Marcucci, Gemma ; Brandi, Maria Luisa

INTRODUCTIONHypoparathyroidism is a rare endocrine disorder characterized by hypocalcaemia and hyperphosphatemia, due to absent or inappropriately low parathyroid hormone levels. For management of chronic hypoparathyroidism, current treatment options involve oral calcium and vitamin D. This standard treatment cannot resolve all problematic aspects of the disease, such as abnormal bone remodeling and reduced quality of life, and is associated with long-term complications, including nephrolithiasis, nephrocalcinosis, renal impairment, cataracts and cerebral calcifications.AREAS COVEREDIn 2015, the FDA (Food and Drug Administration) approved rhPTH (1-84), named Natpara®, a bioengineered recombinant human PTH, for the management of hypoparathyroidism of any etiology, except Autosomal Dominant Hypocalcemia, not well controlled with calcium and active vitamin D. Herein, the authors review its chemistry, pharmacodynamics, pharmacokinetics and clinical efficacy for hypoparathyroidism.EXPERT OPINIONReplacement therapy with rhPTH (1-84) is a fundamental step in the treatment of chronic hypoparathyroidism in cases not well controlled by standard therapy, providing the natural hormone that is lacking for the maintenance of normal calcium levels, and reducing long-term risks associated with conventional therapy. Nevertheless, given the chronic nature of the disease, in the future, further studies will have to be performed to evaluate long-term efficacy and safety of the drug.

100 项与重组人促红素 (华润昂德) 相关的药物交易

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