[Translation] A single-dose, randomized, open-label, two-dose, repeated crossover, four-period, fasting and fed human bioequivalence study of mycophenolate sodium enteric-coated tablets in healthy subjects

主要目的：以重庆迈川医药科技有限公司的麦考酚钠肠溶片（规格：以麦考酚酸（（C17H20O6）计0.18g）为受试制剂，以诺华制药（Novartis Pharma GmbH）的麦考酚钠肠溶片（商品名：Myfortic®/米芙®，规格：180mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using the Mycophenol Sodium Enteric-coated Tablets (specification: 0.18 g based on mycophenolic acid ((C17H20O6)) of Chongqing Maichuan Pharmaceutical Technology Co., Ltd. as the test preparation and the Mycophenol Sodium Enteric-coated Tablets (trade name: Myfortic®/Mifu®, specification: 180 mg) of Novartis Pharma GmbH as the reference preparation, the bioequivalence of the two preparations in healthy humans was investigated according to the relevant provisions of the bioequivalence test. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date17 Feb 2025

Sponsor / Collaborator

Chongqing Maichuan Medical Technology Co., Ltd.

NCT06708988

/ Not yet recruitingNot ApplicableIIT

Predictors of Outcome of Pediatric Renal Transplantation

Renal transplantation is a unique chance to a normal life for end-stage renal disease patients, because of the perfect morphological and functional replacement of the lost kidneys. Serum creatinine and proteinuria reflect kidney allograft function, but they are nonspecific tools.Imaging techniques plays an important role in the detection of anatomical as well as functional abnormalities in the early stages.

Start Date01 Jan 2025

Sponsor / Collaborator

Assiut University

CTR20242297

/ CompletedNot Applicable

一项随机、开放、四周期、完全重复交叉设计评价中国健康受试者空腹单次口服麦考酚钠肠溶片的人体生物等效性试验

[Translation] A randomized, open-label, four-period, completely repeated crossover design to evaluate the bioequivalence of a single oral dose of mycophenolate sodium enteric-coated tablets in Chinese healthy subjects on an empty stomach

主要目的：以广州市微生物研究所集团股份有限公司持有的麦考酚钠肠溶片为受试制剂（规格：0.18g），按生物等效性试验的有关规定，与Novartis Pharma GmbH持有的麦考酚钠肠溶片（商品名：Myfortic（米芙），规格180mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（麦考酚钠肠溶片，T）和参比制剂（商品名：Myfortic（米芙），R）在中国健康成年受试者中的安全性。

[Translation]

Main purpose: Using mycophenolate sodium enteric-coated tablets (specification: 0.18g) held by Guangzhou Institute of Microbiology Group Co., Ltd. as the test preparation, and mycophenolate sodium enteric-coated tablets (trade name: Myfortic, specification 180mg) held by Novartis Pharma GmbH as the reference preparation, a bioequivalence test was conducted according to the relevant provisions of the bioequivalence test to compare the bioequivalence of the two preparations under fasting conditions after a single dose. Secondary purpose: Evaluate the safety of a single oral dose of the test preparation (mycophenolate sodium enteric-coated tablets, T) and the reference preparation (trade name: Myfortic, R) in healthy adult subjects in China.

Start Date23 Jul 2024

Sponsor / Collaborator

Guangzhou Microorganism Research Institute

100 Clinical Results associated with Acute rejection of renal transplant

100 Translational Medicine associated with Acute rejection of renal transplant

0 Patents (Medical) associated with Acute rejection of renal transplant

823

Literatures (Medical) associated with Acute rejection of renal transplant

01 Jun 2025·Autonomic Neuroscience

Renal nerve afferents drive preferential renal sympathoexcitation in response to acute renal ischemia/reperfusion in rats

Article

Author: Lantyer, R ; Santos, D D ; Bergamaschi, C T ; Marreiros, A C ; Milanez, M I O ; Carvalhal, R S ; Gil, C D ; Knuepfer, M M ; Nishi, E E ; Campos, R R

Renal nerve activity is composed of afferent (sensory) and efferent (sympathetic) nerve activity. Ischemia/reperfusion (IR) of the kidney increases renal sympathetic nerve activity (rSNA) and depresses renal function. As the role of renal afferent fibers in acute renal IR is unclear, we tested the hypothesis that renal IR increases rSNA triggered by renal afferent nerves responding to acute ischemia. Two experimental series were performed in adult male Wistar rats. IR was induced by total obstruction of blood flow to the left kidney by clamping the renal artery for 60 min and reperfusion for 120 min. We recorded MAP, HR, rSNA, and splanchnic sympathetic vasomotor activity (sSNA) in 8 normal IR rats and 6 left kidney deafferented IR rats (IR ARD). Renal deafferentation was performed using capsaicin administration to the left renal nerve 2 weeks before the experiments. Blood samples were collected before ischemia and at the end of reperfusion for total and differential leukocyte counts. Renal ischemia significantly increased rSNA 23 % (20 min: 0,07 ± 0,04mVs P < 0.05) but not sSNA. The increase in rSNA was triggered by activation of renal afferent fibers, since IR significantly reduced rSNA in the IR ARD group maximal decrease in frequency 22 % (180 min: -62 ± 29Δspikes/s) and in amplitude 41 % (-0,29 ± 0, 12mVs, P < 0.05) and induced hypotension and bradycardia. However, no significant difference was observed between groups in blood leukocyte profile, but a significant reduction in renal IL-6 was found in IR ARD, suggesting a reduction in renal inflammation in deafferented IR rats. The results show that renal afferent nerves trigger a preferential increase in rSNA and inflammation in the kidney during acute IR.

05 Jan 2024·Cureus

Herpetic Keratitis Following Treatment of Acute Antibody-Mediated Rejection in a Renal Transplantation Recipient

Author: Jayaseelan, Jagadeeshwari ; Parameswaran, Sreejith ; Behera, Geeta ; Sarkar, Sandip

We report an incident case of herpetic keratitis in a renal transplant recipient treated for acute renal allograft rejection. A lady in her forties, a renal transplant recipient on treatment for allograft rejection, was referred with mild ocular symptoms in the right eye for two days. On evaluation, she had mild conjunctival hyperemia and extensive herpetic epithelial keratitis involving the limbal and central corneas. The patient healed without sequelae from the antivirals and lubricants. Viral keratitis in immunosuppressed patients should be suspected, even in patients with mild symptoms, as early initiation of treatment can prevent rapid stromal involvement and scarring.

25 Sep 2023·Angewandte Chemie International Edition

Artificial Urinary Biomarkers for Early Diagnosis of Acute Renal Allograft Rejection

Article

Author: Shen, Jia ; Wang, Rending ; He, Shasha ; Yan, Pengpeng ; Pu, Kanyi ; Cheng, Penghui ; Chen, Jianghua ; Huang, Hongfeng

AbstractAcute renal allograft rejection (ARAR) after kidney transplantation associated with reduced graft survival and eventual graft failure is poorly diagnosed in hospitals. Here, we report the development of Artificial bioMarker Probes (AMPros) for sensitive urinalysis of ARAR in murine models. AMPros spontaneously go to the kidneys after systemic administration, specifically react with the prodromal immune biomarkers to activate their near‐infrared fluorescence signals to report cell‐mediated rejection, and efficiently undergo renal excretion into urine. Thus, AMPros enable convenient optical urinalysis that detects ARAR prior to histological manifestation of rejection, which is also earlier than current diagnostic methods measuring proinflammatory cytokines and peripheral blood lymphocyte mRNAs. Due to the high kidney specificity, AMPros‐based urinalysis discriminates allograft rejection against other non‐alloimmune specific diseases, which is unattainable by measurement of serological biomarkers. Such a noninvasive and sensitive urine test holds great promise in continuous monitoring of renal allograft conditions at low resource settings for timely clinical interventions.

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