scholarly journals Conversion from Calcineurin Inhibitor– to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial

2021 ◽  
Vol 32 (12) ◽  
pp. 3252-3264
Author(s):  
Klemens Budde ◽  
Rohini Prashar ◽  
Hermann Haller ◽  
Maria C. Rial ◽  
Nassim Kamar ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Adverse Events ◽  
Kidney Transplant ◽  
De Novo ◽  
Graft Loss ◽  
Graft Function ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Maintenance Immunosuppression

BackgroundCalcineurin inhibitors (CNIs) are standard of care after kidney transplantation, but they are associated with nephrotoxicity and reduced long-term graft survival. Belatacept, a selective T cell costimulation blocker, is approved for the prophylaxis of kidney transplant rejection. This phase 3 trial evaluated the efficacy and safety of conversion from CNI-based to belatacept-based maintenance immunosuppression in kidney transplant recipients.MethodsStable adult kidney transplant recipients 6–60 months post-transplantation under CNI-based immunosuppression were randomized (1:1) to switch to belatacept or continue treatment with their established CNI. The primary end point was the percentage of patients surviving with a functioning graft at 24 months.ResultsOverall, 446 renal transplant recipients were randomized to belatacept conversion (n=223) or CNI continuation (n=223). The 24-month rates of survival with graft function were 98% and 97% in the belatacept and CNI groups, respectively (adjusted difference, 0.8; 95.1% CI, −2.1 to 3.7). In the belatacept conversion versus CNI continuation groups, 8% versus 4% of patients experienced biopsy-proven acute rejection (BPAR), respectively, and 1% versus 7% developed de novo donor-specific antibodies (dnDSAs), respectively. The 24-month eGFR was higher with belatacept (55.5 versus 48.5 ml/min per 1.73 m2 with CNI). Both groups had similar rates of serious adverse events, infections, and discontinuations, with no unexpected adverse events. One patient in the belatacept group had post-transplant lymphoproliferative disorder.ConclusionsSwitching stable renal transplant recipients from CNI-based to belatacept-based immunosuppression was associated with a similar rate of death or graft loss, improved renal function, and a numerically higher BPAR rate but a lower incidence of dnDSA.Clinical Trial registry name and registration number: A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based, NCT01820572

Cytomegalovirus Disease, Short-Term Cardiovascular Events and Graft Survival in a Cohort of Kidney Transplant Recipients With High CMV IgG Seroprevalence

2021 ◽  
pp. 152692482110027
Author(s):  
James S. Díaz ◽  
Fabián A. Jaimes
Keyword(s):  
Renal Transplant ◽  
Kidney Transplant ◽  
Cardiovascular Events ◽  
Graft Loss ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Cytomegalovirus Disease ◽  
Risk Of Death ◽  
Cmv Disease

Introduction: Both cytomegalovirus (CMV) infection and CMV disease have been linked with several long-term indirect effects in kidney transplant recipients. Research questions: We conducted a retrospective study to assess the association between cytomegalovirus disease and risks of death, shortterm cardiovascular events and graft loss in a cohort of renal transplant recipients. Design: The associations between CMV disease and death and cardiovascular events were determined using Cox regression models, while the association between viral disease and graft loss risk was analyzed through a competing risks regression according to the Fine and Gray method. Death with a functioning graft was considered as a competing risk event. Results: A total of 865 consecutive renal transplant recipients were included. The prevalence of seropositive donor/seronegative recipient (D+/R-) group was 89.9% with the remaining patients classified as seropositive recipient (R+). After median follow-up time of 24.4 months, CMV disease was not a risk factor for all-causes mortality (HR = 1.75; 95% CI 0.94-3.25), early cardiovascular events (HR = 0.54; 95% CI 0.16-1.82) or graft loss (subhazard ratio [the HR adjusted for competing risk of death with functioning graft] = 0.99; 95% CI 0.53-1.84). Conclusions: In this cohort with high prevalence of CMV IgG antibodies, we found no association between cytomegalovirus disease and risk of death or graft loss. The relationship between CMV and cardiovascular disease remains to be unraveled and probably corresponds to a multifactorial phenomenon involving individual risk factors and the immune response to infection rather than the virus effect itself.

scholarly journals Ramadan Fasting in Kidney Transplant Recipients: A Single-Centre Retrospective Study

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Ihab A. Ibrahim ◽  
Ehab A. Hassan ◽  
Abdelrahman M. Alkhan ◽  
Mohamed A. Hussein ◽  
Ahmed F. Alhabashi ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Kidney Transplant ◽  
Graft Function ◽  
Urinary Protein Excretion ◽  
Urinary Protein ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Protein Excretion ◽  
The Impact

Background. Fasting during the lunar month of Ramadan is mandatory to all healthy adult Muslims. Renal transplant recipients are often worried about the impact of fluid and electrolyte deprivation during fasting on the function of their allograft. We aimed to examine the effect of fasting Ramadan on the graft function in renal transplant recipients. Methods. This retrospective cohort study included patients who underwent kidney transplantation in our tertiary referral center. Baseline pre-Ramadan estimated glomerular filtration rate (eGFR), mean arterial pressure (MAP), and urinary protein excretion were compared to those during and after Ramadan within and between the fasting and non-fasting groups. Results. The study population included 280 kidney transplant recipients who chose to fast during the Ramadan month (June-July 2014) and 285 recipients who did not fast. In the fasting group, baseline eGFR did not change from that during or post-Ramadan (72.6±23.7 versus 72.3±24.5 mL/min/1.73 m2, P=0.53; and 72.6±23.7 versus 72±23.2 mL/min/1.73 m2, P=0.14, respectively). Compared to baseline, there were no significant differences between the fasting and the non-fasting groups in terms of mean percent changes in eGFR, MAP, and urinary protein excretion. Conclusion. Fasting during the month of Ramadan did not have significant adverse effects on renal allograft function.

scholarly journals A Comparison of Different Valgancyclovir Formulations in the Universal 6-Month Prophylaxis Against CMV Infection in Renal Transplant Recipients: A Randomized Single-Centre Study

PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 47-55
Author(s):  
Nikolina Basic-Jukic ◽  
Vesna Furic-Cunko ◽  
Tvrtko Hudolin ◽  
Zoran Zimak ◽  
Jason Kirincich ◽  
...  
Keyword(s):  
High Risk ◽  
Adverse Events ◽  
Kidney Transplant ◽  
De Novo ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Cmv Infection ◽  
Serious Adverse Events ◽  
Data Set

Abstract Introduction: Cytomegalovirus (CMV) is the most common opportunistic infective pathogen in kidney transplant recipients. Valganciclovir (VAL) is commonly used for prophylaxis, especially in high-risk recipients. Generic VAL formulations have become available, but the data about their safety and efficacy are lacking. Methods: Consecutive de novo kidney transplant patients were randomized to generic VAL Valganciklovir Teva® (VT group)(24 patients) or Alvanocyte® (A group), Alvogen (19 patients) or to Valcyte® (V group), Roche (23 patients) in a 18-month open-label study. Universal prophylaxis was used for 6 months after the transplantation. CMV DNA levels were measured at 1,3,6,9,12 and 18 months after the transplantation. All positive measurements of CMV DNA were recorded. Results: Groups did not differ regarding the clinical characteristics or the risk for developing CMV infection in the post-transplant period. CMV replications were most common at 9 months after the transplantation with rates of 9% for the V, 13% for the VT and 26% for the A group (p=0.26). At 12 months, positive CMV DNA was recorded in 22%, 8% and 11 % of patients taking V, VT and A, respectively (p=0.37). Rates of biopsy-proven acute rejection, adverse events, and serious adverse events were similar for all formulations. Lymphocele occurred most commonly in the V group (35%) compared to 17% in VT and 17% in the A group (p=0.23). One patient from each of the A and VT groups developed CMV disease. Additionally, they were the only two patients with CMV DNA copies above 656 IU/ml. Glomerular filtration rates were similar in all groups at all time points, while proteinuria was significantly higher at 12 months in patients who received V 0.32 g/day (0.18 – 0.42), compared to patients on VT 0.2 (0.1 – 0.2), or A 0.2 (0.2 – 0.3), p=0.04. Conclusion: Valgancyclovir efficacy and safety in this limited data set is similar with early administration of V, VT and A after kidney transplantation. Additional studies aimed at elucidating the effectiveness of this treatment regimen in patients who are at high risk for developing CMV infection are necessary to draw further conclusions.

Human BK Polyomavirus Nephropathy (BKVN) In Non- Kidney-Transplant Patients

2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S118-S118
Author(s):  
Y Chen Wongworawat ◽  
C Zuppan
Keyword(s):  
Renal Transplant ◽  
Kidney Transplant ◽  
Graft Loss ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Transplant Patients ◽  
Bk Polyomavirus ◽  
Pathologic Features ◽  
Renal Biopsies ◽  
Renal Transplant Patients

Abstract Introduction/Objective Human BK polyomavirus nephropathy (BKVN) occurs in up to 10% of renal transplant recipients, and can result in graft loss. Transplant biopsy is the gold standard to diagnose BKVN, and SV40 immunohistochemical (IHC) staining is helpful in confirming the diagnosis. BKVN is uncommon outside the setting of renal transplantation. To understand more about its occurrence in other contexts, we reviewed our renal biopsies files for cases of BKVN. Methods Our renal biopsy files for the past 20 years were reviewed for all cases with a diagnosis of BKVN or polyoma virus infection, and the clinical characteristics of the affected patients noted. Results Evidence of BKVN was found in 44 renal biopsies, of which 39 (86%) were renal transplant patients. Of the remaining five patients (14%), two had undergone heart transplantation, one lung transplantation, one was undergoing chemotherapy for acute lymphoblastic leukemia, and one patient had active HIV infection. All patients had elevated serum creatinine, and four out of five patients had documented BK viremia. Four of the five biopsies showed typical tubular injury with viral nuclear cytopathic changes (inclusions). In the lung transplant patient, the biopsy showed advanced chronic tubulointerstitial injury without distinct viral inclusions, but SV40 staining confirmed the presence of BK virus antigen. Conclusion The BKVN is distinctly uncommon outside the context of kidney transplantation. In our series, 14% of patients with BKVN were not kidney transplant recipients, but all were immune compromised in some fashion. The pathologic features of BKVN appear similar, regardless of whether the host is a renal transplant recipient or not. Although uncommon, it is important to consider the possibility of BKVN in non-renal transplant patients with persistent or progressive renal dysfunction.

scholarly journals Effects of Rituximab on the Development of Viral and Fungal Infections in Renal Transplant Recipients

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Samir J. Patel ◽  
Jennifer M. Devos ◽  
Richard J. Knight ◽  
Kyle L. Dawson ◽  
Wadi N. Suki ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Odds Ratio ◽  
Viral Infections ◽  
Fungal Infections ◽  
Graft Function ◽  
Deceased Donor ◽  
Infectious Complications ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

Background. Rituximab is becoming increasingly utilized in renal transplant recipients; however, its association with infections remains unclear. Methods. We reviewed the incidence of viral and fungal infections in kidney transplant recipients treated with () or without () rituximab (RTX) in addition to standard immunosuppression. Results. Infections occurred in 134 (30%) patients, with a greater proportion in RTX versus no RTX patients (47% versus 28%; ). Viral infections occurred in 44% and 27% of RTX and no RTX patients, respectively (). This was largely driven by the frequency of BK viremia and noncytomegalovirus/non-BK viruses in RTX patients (27% versus 13% () and 15% versus 2% (), resp.). Fungal infections also occurred more often in RTX patients (11% versus 3 %; ). Multivariate analysis revealed deceased donor recipient (odds ratio = 2.5; ) and rituximab exposure (odds ratio = 2.2; ) as independent risk factors for infection. Older patients, deceased donor recipients, those on dialysis longer, and those with delayed graft function tended to be at a greater risk for infections following rituximab. Conclusions. Rituximab is associated with an increased incidence of viral and fungal infections in kidney transplantation. Additional preventative measures and/or monitoring infectious complications may be warranted in those receiving rituximab.

scholarly journals COVID-19 in Renal Transplant Recipients: Case Series and a Brief Review of Current Evidence

Nephron ◽  
2020 ◽  
pp. 1-7
Author(s):  
Muhammed Ahmed Elhadedy ◽  
Yazin Marie ◽  
Ahmed Halawa
Keyword(s):  
Renal Transplant ◽  
Kidney Transplant ◽  
Therapy Monitoring ◽  
Intensive Therapy ◽  
Current Evidence ◽  
Intensive Care Treatment ◽  
Renal Transplant Recipients ◽  
Supportive Treatment ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

By April 26, 2020, infections related to coronavirus disease 2019 (COVID-19) affected people from 210 countries and caused 203,818 reported deaths worldwide. A few studies discussed the outcome of COVID-19 in kidney transplant recipients. This short series demonstrates our experience in managing COVID-19 disease in renal transplant patients in the absence of strong evidence. We report 8 cases of kidney transplant recipients infected with COVID-19 (median age = 48.5 years; range = 21–71 years), including 4 males and 4 females. The most frequently associated comorbidity was hypertension. The most common presenting features were fever and cough. The main radiological investigation was a portable chest X-ray. Other common features included lymphopenia, high C-reactive protein, and a very high ferritin level. Overall, 1 patient was managed as an outpatient, the remaining 7 required hospital admission, 1 of them referred to the intensive therapy unit. Management included supportive treatment (intravenous fluid therapy, monitoring renal function, and symptomatic treatment with or without ward-based oxygen therapy depending on oxygen saturation) and discontinuation of the antiproliferative immunosuppressive drugs. Seven patients recovered and discharged home to self-isolate. One patient required intensive care treatment and mechanical ventilation. Supportive treatment could be sufficient for the management or to be tried first. We also found that short hospital stay with self-isolation on discharge reduces the burden on the health service and protect the staff and the public.

Correlation between clinical outcome and tissue inflammatory response in kidney transplant recipients with cryptococcosis

2020 ◽  
Vol 78 (7) ◽  
Author(s):  
Angela S Nishikaku ◽  
Marcel V Soldá ◽  
Giannina Ricci ◽  
Vinicius Ponzio ◽  
Carla Pagliari ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Kidney Transplant ◽  
Transforming Growth Factor ◽  
Granulomatous Inflammation ◽  
Protective Role ◽  
Tissue Response ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Tissue Samples

ABSTRACT Cryptococcosis is the second most common invasive fungal infection reported in renal transplant recipients. Tissue granulomatous inflammation is necessary to contain Cryptococcus infection. This study aims to analyze the granuloma patterns and in situ expression of regulatory T (Treg) immune response in tissue samples from 12 renal transplant recipients with cryptococcosis. Fungal isolates were molecularly identified as Cryptococcus neoformans species complex. A detailed characterization of granulomas in tissue samples from 12 kidney transplant recipients with cryptococcosis was described by checking six lung and six skin biopsies by conventional histology and for immunohistochemical detection of CD4 and Treg markers: forkhead box P3 (FoxP3), interleukin (IL)-10 and transforming-growth factor (TGF)-β. Granulomas were classified as compact, loose or mixed. Patients with mixed (n = 4) and compact (n = 3) granulomatous inflammation patterns were associated with a better prognosis and presented a higher number of CD4+FoxP3+T cells compared to the group of patients with loose granulomas. In counterpart, three out of five patients with loose granulomas died with cryptococcosis. We suggest that Treg may have a protective role in the tissue response to Cryptococcus infection given its association with compact and mixed granulomas in patients with better clinical outcomes.

Cancer prevalence in kidney transplant recipients in two general hospitals from Peru

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21155-21155
Author(s):  
B. E. Beltran ◽  
D. Morales ◽  
M. Medina ◽  
J. Espejo ◽  
R. Castillo ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Kidney Transplant ◽  
De Novo ◽  
Tongue Cancer ◽  
Latency Period ◽  
Lymphoproliferative Disease ◽  
Unknown Primary ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

21155 Background: Malignancy following kidney transplantation is an important medical problem during long-term follow-up. The accrual risk is approximately 100 times greater than the general population. We report some features of the cancers developed in our patient population Methods: We retrospectively reviewed records of 1050 kidney transplant recipients who received both unrelated or related allograft transplants from January 1972 to April 2006 and recorded the incidence of de novo malignancies that developed in this cohort. The study was carried out in two centers in Peru. The statistical method was descriptive and parametrical. Survival was calculated using the Kaplan-Meier method. Results: Forty-six cancer were diagnosed in 42 recipients (4.3%). Twenty six were men and 16 women, mean age was 46.0 years old (range:17–67). Malignancy was diagnosed between 2 to 240 months after transplantation. The tumors included Kaposi's sarcoma (KS) in ten patients, squamous cell carcinoma (SCC) in seven, basal cell carcinoma (BCC) in six, cervix cancer in four, colon and breast cancer in three and hepatocarcinoma in two. Also they were reported one case of small intestine cancer, osteosarcoma, pancreatic cancer, lung cancer, bladder cancer, schwanoma, melanoma, tongue cancer, postransplant lymphoproliferative disease, pelvis renal cancer and carcinomatosis from unknown primary. Thus, KS was the most common malignancy encountered in our series, with a prevalence of 0.95%, followed by SCC observed in 0.66% and BCC found in 0.57% of the patients. The average latency period between transplantation and development of malignancy was 25 months for KS, 72.0 months for SCC and 36.0 months for BCC. KS occurred earlier compared with the other cancers ( P < 0.05); We failed to demonstrate any correlation between age/sex and specific type of cancer. The 10 year - survival was 71%. Conclusions: The prevalence of cancer in our renal transplant recipients was 4.3%. KS and non melanoma skin cancer were the most frequent cancer. Low incidence of postransplant lymphoproliferative disease was found. No significant financial relationships to disclose.

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