Phase 2 Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

Condition:   Cytomegalovirus Disease Interventions:   Drug: NPC-21 Low dose;   Drug: NPC-21 High dose;   Drug: NPC-21 Placebo Sponsor:   Nobelpharma Not yet recruiting
Source: - Category: Research Source Type: clinical trials

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Conclusions. In our study of high-risk KT recipients without CMV prophylaxis, a single ATG dose decreased the risk of CMV infection without increasing the risk of AR or compromising graft or patient survival.
Source: Transplantation - Category: Transplant Surgery Tags: Original Clinical Science—General Source Type: research
Authors: Elihimas Júnior UF, Couto JP, Pereira W, Barros de Oliveira Sá MP, Tenório de França EE, Aguiar FC, Cabral DBC, Alencar SBV, Feitosa SJDC, Claizoni Dos Santos TO, Dos Santos Elihimas HC, Alves EP, José de Carvalho Lima M, Branco Cavalcanti FC, Schwingel PA Abstract Background: Renal replacement therapy (RRT) is a public health problem worldwide. Kidney transplantation (KT) is the best treatment for elderly patients' longevity and quality of life. Objectives: The primary endpoint was to compare elderly versus younger KT recipients by analyzing the risk covariables invo...
Source: Journal of Aging Research - Category: Geriatrics Tags: J Aging Res Source Type: research
In Reply The observed rate of breakthrough disease (2%) during prophylaxis in our study is consistent with the rate in other clinical studies (1%-4%). Both CMV disease cases in the prophylaxis group were receiving intermittent hemodialysis and kidney-adjusted parenteral ganciclovir per manufacturer ’s instructions. Inadequate dosing is unlikely given data showing that in solid organ transplant recipients with advanced kidney dysfunction, manufacturer’s recommended dosing results in relative drug overexposure, not underexposure. Excluding these 2 cases, the odds of CMV disease by 12 months (0.46 [95% CI, 0.191-1...
Source: JAMA - Category: General Medicine Source Type: research
To the Editor Dr Singh and colleagues reported that within the first 12 months after liver transplantation, preemptive therapy resulted in significantly lower rates of cytomegalovirus (CMV) disease compared with primary valganciclovir prophylaxis in 205 CMV-seronegative recipients from seropositive donors. The authors noted that a 1-patient difference in each group would have nullified this outcome. The study reported 2 cases of CMV disease in the prophylaxis group (usually rare), potentially due to inadequate kidney dosing; while this highlights the importance of appropriate dosing, would the outcome have been different h...
Source: JAMA - Category: General Medicine Source Type: research
Basel, 8 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas ® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can he lp healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options. BK virus (BKV) is a m...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
Fight Aging! publishes news and commentary relevant to the goal of ending all age-related disease, to be achieved by bringing the mechanisms of aging under the control of modern medicine. This weekly newsletter is sent to thousands of interested subscribers. To subscribe or unsubscribe from the newsletter, please visit: Longevity Industry Consulting Services Reason, the founder of Fight Aging! and Repair Biotechnologies, offers strategic consulting services to investors, entrepreneurs, and others interested in the longevity industry and its complexities. To find out m...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
We examined risk factors that may have contributed to Cytomegalovirus (CMV) reactivation among patients who underwent lung transplantation (LTx).MethodsWe reviewed medical records of patients who underwent LTx at a tertiary healthcare hospital in South Korea between January 2013 and May 2017. We excluded patients who died within the first year after LTx and those lost to follow-up. CMV reactivation was defined as the detection of CMV titers above 3000 copies/ml regardless of specific symptoms after prophylaxis cessation.ResultsOf 89 patients included, 39 (43.8%) developed CMV reactivation. Of those 39 patients, 16 (41.0%) ...
Source: Lung - Category: Respiratory Medicine Source Type: research
CONCLUSION: Either a higher MPA C₀ or dose is associated with an increased risk of cytopenia, but neither a lower MPA C₀ nor dose is associated with BPAR within the first year of transplantation. Hence, a reduced MPA dose with TAC and corticosteroids might be safe in terms of reducing hematologic abnormalities without causing rejection. PMID: 32567256 [PubMed - in process]
Source: J Korean Med Sci - Category: General Medicine Authors: Tags: J Korean Med Sci Source Type: research
ConclusionsOlder age, BMI, family history of diabetes, tacrolimus use, history of hypertension, polycystic kidney disease, acute rejection, HBV infection, and HCV infection are risk factors for new ‐onset diabetes mellitus after kidney transplantation. Therefore, the clinical implications of these factors warrant attention.
Source: Journal of Diabetes Investigation - Category: Endocrinology Authors: Tags: ORIGINAL ARTICLE Source Type: research
We examined the 10-year experience of Mayo Clinic's kidney paired donation (KPD).We aimed to determine the benefits for the recipients of enrolled ABO/HLA compatible pairs and determine the factors associated with prolonged KPD waiting time. Methods. We performed a retrospective study of 332 kidney transplants facilitated by the Mayo 3-site KPD program from September 2007 to June 2018. Results. The median (interquartile range) time from KPD entry to transplantation was 89 days (42-187 days). The factors independently associated with receiving a transplant>3 months after KPD entry included recipient blood type O an...
Source: Transplantation - Category: Transplant Surgery Tags: Original Clinical Science—General Source Type: research
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