After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called "rejection". One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.
Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That's why we need to find the right dose of steroids for each person to treat this.
TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Sydney Union

[+1]

CTR20231705 / CompletedNot Applicable

吗替麦考酚酯干混悬剂在餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of mycophenolate mofetil dry suspension in humans under fed conditions

本研究考察健康受试者在餐后条件下，单次口服由杭州中美华东制药有限公司提供的吗替麦考酚酯干混悬剂（受试制剂，规格：31.8%）或由中外製薬株式会社持证的吗替麦考酚酯干混悬剂（参比制剂，商品名：Cellcept®，规格：31.8%）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

This study examined healthy subjects taking a single oral administration of mycophenolate mofetil dry suspension (test preparation, specification: 31.8%) provided by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. or manufactured by Zhongwai under postprandial conditions. Pharmacokinetic characteristics of mycophenolate mofetil dry suspension (reference preparation, trade name: Cellcept®, strength: 31.8%) certified by Takashi Co., Ltd. to evaluate the bioequivalence and safety of the two preparations. Provide the basis for registration application of the test preparation.

Start Date03 Jul 2023

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

CTR20231706 / CompletedNot Applicable

吗替麦考酚酯干混悬剂在空腹条件下的人体生物等效性试验

[Translation] Bioequivalence study of mycophenolate mofetil dry suspension in humans under fasting conditions

本研究考察健康受试者在空腹条件下，单次口服由杭州中美华东制药有限公司提供的吗替麦考酚酯干混悬剂（受试制剂，规格：31.8%）或由中外製薬株式会社持证的吗替麦考酚酯干混悬剂（参比制剂，商品名：Cellcept®，规格：31.8%）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

This study examined healthy subjects taking a single oral administration of mycophenolate mofetil dry suspension (test preparation, specification: 31.8%) provided by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. or manufactured by Zhongwai Pharmaceutical Co., Ltd. under fasting conditions. Pharmacokinetic characteristics of mycophenolate mofetil dry suspension (reference preparation, trade name: Cellcept®, strength: 31.8%) certified by Co., Ltd. to evaluate the bioequivalence and safety of the two preparations. This test preparation provides the basis for registration application.

Start Date20 Jun 2023

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Rejection of pancreas transplant

100 Translational Medicine associated with Rejection of pancreas transplant

0 Patents (Medical) associated with Rejection of pancreas transplant

221

Literatures (Medical) associated with Rejection of pancreas transplant

25 Jan 2024·Cureus

Pancreatic Panniculitis: A Case Associated With Acute Pancreatic Allograft Rejection

Author: Wind, Olivia ; Kohanzadeh, Avraham ; Mann, Ranon ; Amin, Bijal ; Srivastava, Pooja ; Liu, Qiang ; Sher, Ariel

We present a unique case of pancreatic panniculitis (PP) in a 42-year-old male with a history of pancreas-after-kidney (PAK) transplant. The patient developed PP due to acute pancreas allograft rejection. Clinical manifestations included fevers, myalgias, arthralgias, and tender erythematous subcutaneous nodules on the lower extremities. A recent hospital admission was noted for acute pancreas allograft rejection related to low tacrolimus levels. Rheumatological and infectious disease workups were negative. Skin nodule punch biopsy confirmed PP with lobular panniculitis, necrotic adipocytes, basophilic debris, and calcification. Pancreatic biopsy showed evidence of parenchymal acute cellular rejection. Lipase and amylase levels were elevated (1781 U/L and 881 U/L, respectively). Treatment involved pulse solumedrol and thymoglobulin for pancreatic rejection, alongside adjustments to immunosuppressive medications. This case highlights the rarity of PP in a PAK recipient and its association with acute pancreas allograft rejection. Importantly, it is the first reported case of PP occurring solely in the context of pancreas transplant rejection, without concurrent kidney damage or rejection. Prompt diagnosis and management led to the resolution of skin and systemic symptoms. In conclusion, this report presents a clinically relevant and unique case of PP resulting from acute pancreas allograft rejection in a PAK transplant recipient. The findings underscore the importance of early diagnosis and management for positive patient outcomes, serving as a reminder to consider underlying pancreatic pathology when encountering PP in transplant recipients.

01 Apr 2023·Transplantation

Higher Fasting Pretransplant C-peptide Levels in Type 2 Diabetics Undergoing Simultaneous Pancreas-kidney Transplantation Are Associated With Posttransplant Pancreatic Graft Dysfunction

Review

Author: Aufhauser, David ; Mandelbrot, Didier ; Parajuli, Sandesh ; Kaufman, Dixon ; Odorico, Jon

Background.Among selected patients with type 2 diabetes mellitus (T2DM), simultaneous pancreas and kidney (SPK) transplants can be an effective option. However, data are limited about outcomes in T2DM SPK recipients based on the pretransplant C-peptide levels.Methods.In this study, we reviewed all T2DM SPK recipients and categorized them based on the pretransplant fasting C-peptide levels into 3 groups: low (≤2 ng/mL), medium (>2–8 ng/mL), and high (>8 ng/mL). Several measures of graft failures (GFs), graft dysfunction, and composite outcomes were of interest.Results.There were a total of 76 SPK recipients (low, n = 14; medium, n = 47; high, n = 15). At the last follow-up, the low group did not reach any outcome; in contrast, 11 (23%) in the medium group and 5 (33%) in the high group reached the uncensored composite outcome; 6 (13%) in the medium group and 2 (13%) in the high group had GF; and 8 (17%) in the medium group and 4 (26.7%) in the high group reached the death-censored composite outcomes. In a fully adjusted model, each pretransplant C-peptide unit was not associated with an increased risk of the composite outcome, GF, or death-censored composite outcomes. However, in multivariate analysis with limited adjustment, pretransplant C-peptide was associated with the composite outcome (hazard ratio: 1.18, 95% confidence interval, 1.01-1.38; P = 0.03) and death-censored composite outcome (hazard ratio: 1.20; 95% confidence interval, 1.01-1.42; P = 0.03).Conclusions.Although limited by the small sample size, we found excellent outcomes among T2DM SPK recipients overall. However, higher levels of pretransplant C-peptide may be associated with inferior posttransplant outcomes that include graft dysfunction.

31 Mar 2023·Gland surgery

Different biopsy techniques for different pancreas graft locations after homolateral simultaneous pancreas-kidney transplantation.

Article

Author: Zhang, Lei ; Zhang, Yirui ; Li, Guanghui ; Jiang, Xiaofeng ; Fang, Jiali ; Yang, Xuewei ; Ma, Junjie ; Yang, Hainan ; Li, Xufeng ; Wan, Jiao ; Li, Li ; Chen, Zheng

BackgroundBiopsy of a transplanted pancreas is sometimes necessary in patients who have undergone simultaneous pancreas-kidney (SPK) transplantation and have elevated serum lipase and amylase concentrations. However, the risks associated with pancreatic graft biopsy are high, and the best biopsy technique for different location of pancreatic graft remains unclear.MethodsDepending on the anatomical location of the transplanted pancreas, percutaneous computed tomography (CT) combined with color Doppler-guided puncture biopsy or laparoscopic biopsy was used to obtain samples of transplanted pancreatic tissue that were shallow and deep, respectively.ResultsAfter SPK transplantation, 4 patients developed abnormal serum lipase and amylase concentrations and underwent pancreas graft biopsy, 1 patient underwent percutaneous CT combined with color Doppler-guided puncture biopsy, 2 patients underwent laparoscopic wedge biopsy, and 1 patient underwent laparoscopic and puncture biopsy. All biopsies were performed successfully, with no intra- or postoperative complications (e.g., bleeding, pancreatic leakage, intestinal leakage). Biopsy sampling was effective in 3 patients, including 1 case of acute pancreatic rejection, 1 case of pancreatitis, and 1 case of pancreatic plasmablastic lymphoma. Biopsy failed to retrieve samples in 1 patient with a deep pancreatic graft who underwent laparoscopic wedge biopsy.ConclusionsPancreas graft biopsy is safe and feasible after SPK transplantation. In addition to the two biopsy methods mentioned, other methods can also be used. Different biopsy strategies should be formulated according to the anatomical location of the transplanted pancreas.

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