Variability in the reporting of renal function endpoints in immunosuppression trials in renal transplantation: time for consensus?

Abstract:

:Early measures of graft function are increasingly used to assess efficacy in clinical trials of kidney transplant immunosuppression. This study aimed to assess the variability and quality of reporting of these endpoints in contemporary trials. Data regarding renal function endpoints were extracted from 213 reports from randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published between 2010 and 2014. A total of 174 (81.7%) reports included a measure of renal function; in 44 (20.7%), this was the primary endpoint. A total of 103 manuscripts (48.4%) reported serum creatinine, 142 (66.6%) reported estimated glomerular filtration rate (eGFR), and 26 (12.2%) reported measured GFR. Formulas used for GFR estimation were modification of diet in renal disease (42.3%), Cockroft-Gault (23.5%), Nankivell (15.0%), and CKD-EPI (0.9%). Six studies (2.8%) did not report the formula used to estimate GFR. A total of 13.9% of endpoints had missing data. In 10 studies, disagreement was found in the significance of findings using different measures of renal function. There is a great deal of variability in the reporting of renal function endpoints, with a significant proportion of studies using underperforming or inappropriate estimates. There is a need for consensus as to the best tool for monitoring and reporting renal function post-transplant, and in particular for use in clinical trials and registries.

journal_name

Clin Transplant

journal_title

Clinical transplantation

authors

Knight SR,Hussain S

doi

10.1111/ctr.12861

subject

Has Abstract

pub_date

2016-12-01 00:00:00

pages

1584-1590

issue

12

eissn

0902-0063

issn

1399-0012

journal_volume

30

pub_type

杂志文章
  • Apolipoprotein E gene polymorphism in renal transplant recipients: effects on lipid metabolism, atherosclerosis and allograft function.

    abstract:INTRODUCTION:Atherosclerosis is a serious complication and leading cause of mortality in renal transplant recipients (RTRs). Hyperlipidemia may be associated with progression of renal disease and chronic allograft dysfunction. Similarities in the pathogenesis of glomerulosclerosis and atherosclerosis have been proposed...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2004.00162.x

    authors: Kahraman S,Kiykim AA,Altun B,Gençtoy G,Arici M,Gulsun M,Erdem Y,Yasavul U,Turgan C,Cağlar S

    更新日期:2004-06-01 00:00:00

  • Anemia following renal transplantation: erythropoietin response and iron deficiency.

    abstract::To define the etiology of anemia post-renal transplantation, we assessed hematologic parameters and EPO levels in 38 anemic and 16 non-anemic control renal transplant recipients (RTRs) with varying degrees of allograft function at periods > 3 months post-transplantation. Significant differences between the two groups ...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:

    authors: Miles AM,Markell MS,Daskalakis P,Sumrani NB,Hong J,Sommer BG,Friedman EA

    更新日期:1997-08-01 00:00:00

  • Influence of immunosuppressive regimens on short-term morbidity and mortality in heart transplantation.

    abstract:BACKGROUND:The goal of immunosuppressive therapy in heart transplantation is to maximize safety and efficacy while minimizing morbidity and mortality. We now have numerous drug combinations, but few have been compared with each other. AIM:To compare various immunosuppressive regimens assessing morbidity and mortality ...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2007.00751.x

    authors: Aguero J,Almenar L,Martínez-Dolz L,Moro JA,Rueda J,Raso R,Chamorro C,Sanchez JM,Salvador A

    更新日期:2008-01-01 00:00:00

  • Monitoring changes in cyclosporine dosage by trough level testing.

    abstract::The concept of a narrow therapeutic window has guided the management of transplant recipients on cyclosporine immunosuppression since its inception more than a decade ago. The need to maintain immunosuppression and avoid toxicity imposed the requirement of monitoring cyclosporine levels within a limited range. The use...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:

    authors: Takasugi M,Takasugi JK,Barba L

    更新日期:1995-04-01 00:00:00

  • Multicultural issues in organ transplantation: the influence of patients' cultural perspectives on compliance with treatment.

    abstract::The potential influence of racially or ethnically diverse cultural perspectives on patient compliance with post-transplant treatments is discussed. Domains of competency regarding culturally sensitive clinical practice are outlined to assist providers in better understanding the perspectives that may influence the vie...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:

    authors: Prieto LR,Miller DS,Gayowski T,Marino IR

    更新日期:1997-12-01 00:00:00

  • Response to antiviral therapy in liver transplant recipients with recurrent hepatitis C viral infection: a single center experience.

    abstract:INTRODUCTION:Recurrence of hepatitis C virus (HCV) in hepatic allograft is a major concern after successful liver transplant (LTx). AIM:To examine the response rate to pegylated interferon (PEG-IFN) and ribavirin in post-LTx patients with HCV recurrence. PATIENTS AND METHODS:Between January 2003 and September 2006, 6...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2009.00961.x

    authors: Jain A,Sharma R,Ryan C,Safadjou S,Kashyap R,Mantry P,Maliakkal B,Orloff M

    更新日期:2010-01-01 00:00:00

  • Perspectives on donor lung allocation from both sides of the Atlantic: The United States.

    abstract::Donor lung allocation in the United States focuses on decreasing waitlist mortality and improving recipient outcomes. The implementation of allocation policy to match deceased donor lungs to waitlisted patients occurs through a unique partnership between government and private organizations, namely the Organ Procureme...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.13873

    authors: Tsuang WM,Snyder LD,Budev MM

    更新日期:2020-07-01 00:00:00

  • Candida infections in solid organ transplantation: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice.

    abstract::These updated guidelines from the American Society of Transplantation Infectious Diseases Community of Practice provide recommendations for the diagnosis and management of Candida infections in solid organ transplant recipients. Candida infections manifest primarily as candidemia and invasive candidiasis and cause con...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.13623

    authors: Aslam S,Rotstein C,AST Infectious Disease Community of Practice.

    更新日期:2019-09-01 00:00:00

  • Comparison of nutritional status in hemodialysis patients with and without failed renal allografts.

    abstract:BACKGROUND:The survival of patients returning to hemodialysis (HD) following kidney transplant failure is unfavorable. However, the factors responsible for this poor outcome are largely unknown; chronic inflammation due to failed allograft and malnutrition may contribute to morbidity and mortality. We aimed to compare ...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2009.01097.x

    authors: Yelken BM,Gorgulu N,Caliskan Y,Yazici H,Turkmen A,Yildiz A,Sever MS

    更新日期:2010-07-01 00:00:00

  • Kidney graft survival in patients with hepatitis C: a single center experience.

    abstract::Hepatitis C virus (HCV) infection is highly prevalent in renal transplant candidates; however, its effect on the transplant outcome is still controversial. The aim of the present study was to determine the effect of HCV infection in the outcome of kidney transplantation in a single transplant center. The study populat...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2007.00679.x

    authors: Arango J,Arbelaez M,Henao J,Mejia G,Arroyave I,Carvajal J,Garcia A,Gutierrez J,Velásquez A,Garcia L,Aguirre C

    更新日期:2008-01-01 00:00:00

  • Liver allocation: urgency of need or prospect of success? Ethical considerations.

    abstract::In German legislation and in Eurotransplant's practice of liver allocation, urgency of need is considered as the primary distribution criterion. However, at a certain stage, the "sickest-first" principle is regarded as counterproductive as the performance status of these patients receiving an organ is on average criti...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.12154

    authors: Bobbert M,Ganten TM

    更新日期:2013-07-01 00:00:00

  • Sirolimus-based rescue therapy after rejection in liver transplantation.

    abstract::Steroid-resistant acute rejection (SR-AR) and ductopenic rejection (DR) after liver transplantation are infrequent, but difficult to manage. We performed a retrospective review of patients with SR-AR or DR treated with sirolimus-based therapy. Since 2002, we have treated five patients with SR-AR and eight patients wit...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2008.00906.x

    authors: Lladó L,Fabregat J,Castellote J,Ramos E,Torras J,Serrano T,Figueras J,Rafecas A

    更新日期:2009-01-01 00:00:00

  • A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

    abstract::An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving thei...

    journal_title:Clinical transplantation

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/ctr.12256

    authors: Bloom RD,Trofe-Clark J,Wiland A,Alloway RR

    更新日期:2013-11-01 00:00:00

  • Regional differences in deceased donor liver transplantation and their implications for organ utilization and allocation.

    abstract::We examined the UNOS database from 7/15/00-7/17/05 for Regional deceased donor liver utilization. For each region, we performed logistic regression and derived odds ratios (OR) for donor characteristics associated with livers being transplanted outside of the region or not transplanted at all. Regions with smallest an...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2010.01214.x

    authors: Hayashi PH,Axelrod DA,Galanko J,Salvalaggio PR,Schnitzler M

    更新日期:2011-01-01 00:00:00

  • Rejection after conversion to a proliferation signal inhibitor in chronic heart transplantation.

    abstract::We sought to determine the incidence, risk factors, and consequences of acute rejection (AR) after conversion from a calcineurin inhibitor (CNI) to a proliferation signal inhibitor (PSI) in maintenance heart transplantation. Relevant clinical data were retrospectively obtained for 284 long-term heart transplant recipi...

    journal_title:Clinical transplantation

    pub_type: 杂志文章,多中心研究

    doi:10.1111/ctr.12241

    authors: González-Vílchez F,Vázquez de Prada JA,Paniagua MJ,Almenar L,Mirabet S,Gómez-Bueno M,Díaz-Molina B,Arizón JM,Delgado J,Pérez-Villa F,Crespo-Leiro MG,Martínez-Dolz L,Roig E,Segovia J,Lambert JL,Lopez-Granados A,Escribano P

    更新日期:2013-11-01 00:00:00

  • The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program.

    abstract::Although patients within a transplant program are awaiting or have received disease modifying or curative treatment, they are also facing advanced illness and the possibility of death. The involvement of specialized palliative care services for these patients may improve symptom management and facilitate advance care ...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.12838

    authors: Wentlandt K,Dall'Osto A,Freeman N,Le LW,Kaya E,Ross H,Singer LG,Abbey S,Clarke H,Zimmermann C

    更新日期:2016-12-01 00:00:00

  • Pleural catheter placement and intrapleural fibrinolysis following lung transplantation.

    abstract:BACKGROUND:This study aimed to investigate the characteristics of lung transplant recipients requiring additional pleural drainage catheters early post-lung transplantation and to determine the safety and efficacy of intrapleural fibrinolytics in these patients. METHODS:A retrospective review of lung transplant recipi...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.13592

    authors: Kao CC,Cuevas JF,Tuthill S,Parulekar AD

    更新日期:2019-06-01 00:00:00

  • Orthotopic placement of a segmental pancreas graft for transplant: a case report.

    abstract::Pancreas retransplantation has become more frequent and represents a technical challenge for surgeons. Knowledge of alternative surgical options could be useful in difficult cases. We present a case of brutal diabetes mellitus in a patient with severe vascular disease that underwent a third pancreas transplant. Diffic...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2009.01149.x

    authors: Garcia-Roca R,Humar A,Sturdevant M,Kobayashi T,Dunn T,Kandaswamy R,Sutherland D

    更新日期:2010-05-01 00:00:00

  • A prospective randomized study comparing cyclosporine versus tacrolimus combined with daclizumab, mycophenolate mofetil, and steroids in heart transplantation.

    abstract:BACKGROUND:Cyclosporine (CsA) and tacrolimus (Tac) in heart transplantation (HTx) have been compared but with certain drawbacks. We compared both drugs in a prospective analysis with medium-term follow-up. METHODS:Hundred and six patients were randomized to receive CsA or Tac (53 per group). Target levels of CsA were ...

    journal_title:Clinical transplantation

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1399-0012.2010.01309.x

    authors: Sánchez-Lázaro IJ,Almenar L,Martínez-Dolz L,Buendía-Fuentes F,Agüero J,Navarro-Manchón J,Vicente JL,Salvador A

    更新日期:2011-07-01 00:00:00

  • Parvovirus B19 infection in a liver transplant recipient: case report and review in organ transplant recipients.

    abstract::We report an adult liver transplant recipient with parvovirus B19 infection, presenting as chronic transfusion-dependent anemia ensuing 1 month post-transplantation. Both serum and bone marrow cells were positive for parvovirus B19 DNA detected by polymerase chain reaction. The bone marrow biopsy revealed erythroid hy...

    journal_title:Clinical transplantation

    pub_type: 杂志文章,评审

    doi:

    authors: Chang FY,Singh N,Gayowski T,Marino IR

    更新日期:1996-06-01 00:00:00

  • Differential gene expression pattern in biopsies with renal allograft pyelonephritis and allograft rejection.

    abstract::Differentiating acute pyelonephritis (APN) from acute rejection (AR) in renal allograft biopsies can sometimes be difficult because of overlapping clinical and histologic features, lack of positive urine cultures,and variable response to antibiotics. We wanted to study differential gene expression between AR and APN u...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.12795

    authors: Oghumu S,Nori U,Bracewell A,Zhang J,Bott C,Nadasdy GM,Brodsky SV,Pelletier R,Satoskar AR,Nadasdy T,Satoskar AA

    更新日期:2016-09-01 00:00:00

  • No apparent impact of increased post-operative blood glucose levels on clinical outcome in kidney transplant recipients.

    abstract:BACKGROUND:Our objective is to evaluate whether hyperglycemia in the first 48 h after renal transplantation is independently associated with rejection, post-operative infection and post-transplant diabetes mellitus (PTDM) in a retrospective cohort study. METHODS:Patients who received a renal transplant in our hospital...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2008.00910.x

    authors: van den Berg TJ,Bogers H,Vriesendorp TM,Surachno JS,DeVries JH,ten Berge IJ,Hoekstra JB

    更新日期:2009-03-01 00:00:00

  • The use of flow cytometry for the detection of CMV-specific antigen (pp65) in leukocytes of kidney recipients.

    abstract::Flow cytometric assay (FCA) was used to detect a cytomegalovirus (CMV) specific antigen (pp65) in CMV-infected fibroblast cells and in leukocytes of kidney recipients. FCA distinguished clearly between the infected and non-infected fibroblast cells. Regarding transplant patients, the FCA was positive when the number o...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1034/j.1399-0012.2000.140208.x

    authors: Essa S,Pacsa AS,Al-Attiyah R,El-Shazly A,Raghupathy R,Said T

    更新日期:2000-04-01 00:00:00

  • Nitric oxide attenuates ischaemia-reperfusion (I/R) injury in the diabetic liver.

    abstract:BACKGROUND:Liver ischaemia-reperfusion (I/R) occurs during resuscitation from haemorrhagic shock, hepatic transplantation and anatomic resection of the liver. This injury is associated with hepatocellular enzyme release and hepatocyte necrosis. The impact of chronic illnesses such as diabetes mellitus (DM) on hepatic I...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2004.00210

    authors: Rogers H 3rd,Zibari GB,Roberts J,Turnage R,Lefer DJ

    更新日期:2004-01-01 00:00:00

  • Peritoneal metastasis of intracranial glioblastoma via a ventriculoperitoneal shunt preventing organ retrieval: case report and review of the literature.

    abstract::The case of patient with glioblastoma metastatic to the peritoneal cavity 9 months after ventriculoperitoneal shunt surgery precluding cadaver organ procurement is presented. Even though central nervous tumors rarely metastasize spontaneously, the literature indicates that systemic metastases are related to previous s...

    journal_title:Clinical transplantation

    pub_type: 杂志文章,评审

    doi:

    authors: Fecteau AH,Penn I,Hanto DW

    更新日期:1998-08-01 00:00:00

  • Monitoring of cyclosporine levels in transplant recipients using self-administered fingerprick sampling.

    abstract::Use of C(2) monitoring for cyclosporine A (CsA) microemulsion results in improved clinical outcomes vs. trough (C(0)) monitoring. Logistical issues include accurate timing of the C(2) sample; requirement for sample dilution with most standard assay techniques; and inconvenience for patients. Recently, it has been show...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2005.00472.x

    authors: Yonan N,Martyszczuk R,Machaal A,Baynes A,Keevil BG

    更新日期:2006-03-01 00:00:00

  • Liver transplant center risk tolerance.

    abstract::Recent changes in Center for Medicare & Medicaid Services (CMS) condition for participation, using benchmark volume/outcomes requirements for certification, have been implemented. Consequently, the ability of a transplant center to assess its risk tolerance is important in successful management. An analysis of SRTR da...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/j.1399-0012.2012.01658.x

    authors: Johnson SR,Karp SJ,Curry MP,Barugel M,Rodrigue JR,Mandelbrot DA,Rogers CP,Hanto DW

    更新日期:2012-05-01 00:00:00

  • Steroid withdrawal in kidney transplant recipients: is it a safe option?

    abstract::The long-term side effects of lifelong steroid immunosuppression are well documented, therefore, steroid withdrawal (SW) if safe would clearly be of benefit. From 1987-1996, 470 kidney transplants were performed at our institution. During this time period, steroid withdrawal was offered to a select group of patients (...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:

    authors: Sanfey H,Haussman G,Isaacs I,Ishitani M,Lobo P,McCullough C,Pruett T

    更新日期:1997-10-01 00:00:00

  • Caring for the pregnant kidney transplant recipient.

    abstract::As fertility can be restored to normal soon after a kidney transplant, it is important for physicians caring for recipients to be able to inform the patient about the potential risks of pregnancy. Current opinion is that pregnancy can be successful if carried out under optimal circumstances, including stable allograft...

    journal_title:Clinical transplantation

    pub_type: 杂志文章,评审

    doi:10.1111/j.1399-0012.2011.01492.x

    authors: Concepcion BP,Schaefer HM

    更新日期:2011-11-01 00:00:00

  • Serial perfusion in native lungs in patients with idiopathic pulmonary fibrosis and other interstitial lung diseases after single lung transplantation.

    abstract:BACKGROUND:Lung perfusions after single lung transplantation (SLT) have not been fully clarified in patients with interstitial lung disease (ILD). The present study aimed to investigate temporal changes in native lung perfusion and their associated clinical factors in patients with ILD who have undergone SLT. METHODS:...

    journal_title:Clinical transplantation

    pub_type: 杂志文章

    doi:10.1111/ctr.12701

    authors: Sokai A,Handa T,Chen F,Tanizawa K,Aoyama A,Kubo T,Ikezoe K,Nakatsuka Y,Oguma T,Hirai T,Nagai S,Chin K,Date H,Mishima M

    更新日期:2016-04-01 00:00:00