scholarly journals PREBIOTIC: A Study Protocol of a Randomised Controlled Trial to Assess Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Feasibility Study

2021 ◽  
Author(s):  
Samuel Chan ◽  
Carmel M Hawley ◽  
Elaine M Pascoe ◽  
Christopher Cao ◽  
Katrina L Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Transplant ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Trial Registration ◽  
Feasibility Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Randomised Controlled

Abstract BackgroundModulating the microbiota in the large intestine of kidney transplant recipients through prebiotic supplementation may prevent infectious complications from occurring. To date, there have been no interventional trials which have investigated this novel treatment in kidney transplantation. The aim of PREBIOTIC is to assess the feasibility of performing a randomised controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in kidney transplant recipients.MethodsSixty kidney transplant patients will be recruited to a double-blind, placebo-controlled, randomised feasibility trial. Patients will be provided with prebiotic therapy or placebo for four to six weeks. Outcomes will include recruitment, adherence, tolerance, retention, laboratory parameters (including serum indoxyl sulphate, ρ-cresyl sulphate and stool collection), patients’ self-assessed quality of life, gastrointestinal symptoms and clinical outcomes.DiscussionThis trial will assess the feasibility of prebiotic supplementation in kidney transplant recipients. Prebiotics may not only alter the gut microbiota and their inherent metabolism and production of uraemic toxins, but may also prevent infections from occurring in kidney transplant recipients.Trial RegistrationAustralian New Zealand Clinical Trials Registry number ACTRN12618001057279p. The date of registration was 25th June 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375370&isReview=true.

scholarly journals Immunosuppression reduction when administering a booster dose of the BNT162b2 mRNA SARS-CoV-2 vaccine in kidney transplant recipients without adequate humoral response following two vaccine doses: protocol for a randomised controlled trial (BECAME study)

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e055611
Author(s):  
Dafna Yahav ◽  
Benaya Rozen-Zvi ◽  
Tiki Mashraki ◽  
Alaa Atamna ◽  
Haim Ben-Zvi ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Transplant ◽  
Controlled Trial ◽  
Vaccine Dose ◽  
Ethics Committee ◽  
Inadequate Response ◽  
Solid Organ ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Randomised Controlled

IntroductionInadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients.Methods and analysisBECAME is a single-centre, open-label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participants per arm will be also tested for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ~350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial.Ethics and disseminationThe trial is approved by local ethics committee of Rabin Medical Center (RMC-0192-21). All participants will be required to provide written informed consent. Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee.Trail registration numberNCT04961229.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

scholarly journals Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double‐blind, randomized, placebo‐controlled trial

2019 ◽  
Vol 19 (6) ◽  
pp. 1831-1837 ◽  
Author(s):  
Samir J. Patel ◽  
Richard J. Knight ◽  
Samantha A. Kuten ◽  
Edward A. Graviss ◽  
Duc T. Nguyen ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Controlled Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind

scholarly journals Protocol for a pilot single-centre, parallel-arm, randomised controlled trial of dietary inulin to improve gut health in solid organ transplantation: the DIGEST study

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e049184
Author(s):  
Julian Singer ◽  
Yan Jun Li ◽  
Tracey Ying ◽  
Leyla J Aouad ◽  
David M Gracey ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Solid Organ Transplantation ◽  
Gastrointestinal Symptoms ◽  
Solid Organ ◽  
Transplant Recipients ◽  
Gut Health ◽  
Kidney Transplant Recipients ◽  
Single Centre ◽  
Post Transplant ◽  
Randomised Controlled

IntroductionKidney transplantation remains the best treatment for end-stage kidney disease, however the requirement for indefinite immunosuppression increases the risk of cardiovascular disease, cancer and infection, leading to a reduction in long-term patient and graft survival. The gut microbiome is a critical determinant of health and modulates host immunity and metabolism through a number of recognised pathways, including through the production of immunomodulatory short-chain fatty acids (SCFA). Dietary supplementation with non-digestible fibre can augment the microbial production of SCFA and lead to favourable immune and metabolic outcomes, although this has yet to be shown in human kidney transplant recipients.Methods and analysisDietary inulin for gut health in solid-organ transplantation (DIGEST) is a single-centre, unblinded, pilot parallel-arm randomised controlled trial designed to assess the feasibility and adherence of dietary inulin, a naturally occurring dietary fibre, in the early post-transplant period in kidney transplant recipients. Participants will be randomised at day 28 post-transplant to a 4-week period of dietary inulin (10–20 g/day) in addition to standard care, or standard care alone, and followed-up until week 12 post-transplant.The primary outcomes of the study are: (i) the feasibility of participant recruitment, randomisation and retention; (ii) adherence to the intervention (inulin) and (iii) the tolerability of inulin determined by changes in gastrointestinal symptoms as scored on the Gastrointestinal Symptom Rating Scale.Secondary outcomes include: (1) glycaemic variability determined by continuous glucose monitoring; (2) abundance of SCFA-producing microbiota, as determined by 16s rRNA sequencing of the faecal metagenome; (3) serum SCFA concentrations; (4) peripheral blood immune cell populations; (5) recipient inflammatory and metabolic profiles and (6) the incidence of biopsy-proven acute rejection and kidney function determined by estimated glomerular filtration rate.Ethics and disseminationAll study visits, clinical and laboratory assessments will be integrated into usual post-transplant care, creating no additional healthcare encounters or procedures. The risks associated with this study are minor. Inulin has been shown to be well tolerated across a variety of cohorts, with the occurrence of short-term adverse gastrointestinal symptoms self-limiting. However, with gastrointestinal adverse events common following kidney transplantation, the tolerability of inulin in this cohort remains unknown. The results of DIGEST will be published in peer-reviewed journals and presented at academic conferences. This study has been approved by the Sydney Local Health District’s Ethics Committee (Royal Prince Alfred Hospital Zone).Trial registration numberACTRN12620000623998.

scholarly journals METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuanyuan Wang ◽  
Andrew J. Teichtahl ◽  
Graeme Jones ◽  
Helen I. Keen ◽  
Catherine L. Hill ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Trial Registration ◽  
Positive Trial ◽  
Hand Osteoarthritis ◽  
Double Blind ◽  
Structural Progression ◽  
Randomised Controlled

Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124

scholarly journals Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Julie H. Ishida ◽  
Anita Patel ◽  
Aneesh K. Mehta ◽  
Philippe Gatault ◽  
Jacqueline M. McBride ◽  
...  
Keyword(s):  
High Risk ◽  
Kidney Transplant ◽  
Controlled Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Cmv Infection ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Cmv Disease

ABSTRACT Cytomegalovirus (CMV) infection is a significant complication after kidney transplantation. We examined the ability of RG7667, a combination of two monoclonal antibodies, to prevent CMV infection in high-risk kidney transplant recipients in a randomized, double-blind, placebo-controlled trial. CMV-seronegative recipients of a kidney transplant from a CMV-seropositive donor (D+R−) were randomized to receive RG7667 (n = 60) or placebo (n = 60) at the time of transplant and 1, 4, and 8 weeks posttransplant. Patients were monitored for CMV viremia every 1 to 2 weeks posttransplant for 24 weeks. Patients who had seroconverted (D+R+) or withdrawn before dosing were excluded from the analysis (n = 4). CMV viremia occurred in 27 of 59 (45.8%) patients receiving RG7667 and 35 of 57 (61.4%) patients receiving placebo (stratum-adjusted difference, 15.3%; P = 0.100) within 12 weeks posttransplant and in 30 of 59 (50.8%) patients receiving RG7667 and 40 of 57 (70.2%) patients receiving placebo (stratum-adjusted difference, 19.3%; P = 0.040) within 24 weeks posttransplant. Median time to CMV viremia was 139 days in patients receiving RG7667 compared to 46 days in patients receiving placebo (hazard ratio, 0.53; P = 0.009). CMV disease was less common in the RG7667 than placebo group (3.4% versus 15.8%; P = 0.030). Adverse events were generally balanced between treatment groups. In high-risk kidney transplant recipients, RG7667 was well tolerated, numerically reduced the incidence of CMV infection within 12 and 24 weeks posttransplant, delayed time to CMV viremia, and was associated with less CMV disease than the placebo. (This study has been registered at ClinicalTrials.gov under registration no. NCT01753167.)

scholarly journals MO011A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF VITAMIN K SUPPLEMENTATION TO IMPROVE VASCULAR HEALTH IN KIDNEY TRANSPLANT RECIPIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jennifer Lees ◽  
Alastair Rankin ◽  
Keith Gillis ◽  
Luke Zhu ◽  
Elaine Rutherford ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Vitamin K ◽  
Controlled Trial ◽  
Vascular Health ◽  
Transplant Recipients ◽  
Resonance Imaging ◽  
Kidney Transplant Recipients ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background and Aims Vascular stiffness (VS) and calcification (VC) are markers of cardiovascular disease which are prevalent in kidney transplant recipients (KTR) and associated with subclinical vitamin K deficiency. We tested the hypothesis that vitamin K supplementation would reduce VS and VC in prevalent KTR in the Vitamin K for kidney Transplant Organ Recipients: Investigating vEssel Stiffness (ViKTORIES) trial. Method In a single-centre, phase II, parallel-group, randomised, double-blind, placebo-controlled trial (ISRCTN22012044), KTR were randomised 1:1 to vitamin K (menadiol diphosphate 5mg) or placebo thrice weekly for one year. The primary outcome was between-group difference in VS (ascending aortic distensibility by cardiac magnetic resonance imaging) at 1 year by ANCOVA adjusted for the baseline value, age and duration of end-stage kidney disease. Secondary outcomes included VC (coronary artery calcium score on non-contrast computed tomography), cardiac structure and function (on cardiac magnetic resonance imaging), blood pressure, eGFR, proteinuria and quality of life. All outcomes were assessed by intention-to-treat with secondary per-protocol analyses. Missing data were multiply imputed as a sensitivity analysis for the main outcomes. The trial was conducted in accordance with the Declaration of Helsinki and was approved by the West of Scotland Research Ethics Committee 4 (Ref: 17/WS/0101). The results were combined in a meta-analysis with other published data. Results Ninety participants were randomised to vitamin K (n=45) or placebo (n=45) and included in the analysis. Baseline demographics, clinical history and immunosuppression regimens were similar between groups: mean age 57.6 ± 9.6 years, 70% male, with median time after transplantation 7.8 (IQR 3.5 - 13.9) years. There was no impact of vitamin K versus placebo on VS after 12 months (-0.2 (-0.5 - 0.2) vs. -0.3 (-0.6 - 0.1) x10-3 mmHg-1; p=0.60), nor on VC (184 (52 - 315) vs 44 (-89 - 177) units; p=0.11), nor on any other outcome measure. Medication adherence was very good in both groups (90 vs. 95%; p=0.58). Achieved power was 85%. Serious adverse events were common (vitamin K: 26.7 vs. placebo: 60.0%): all serious adverse events were classified as expected. Multiple imputation of missing data had no impact on results of VS or VC outcomes. Combining these with other published results, vitamin K supplementation has no significant observed effect on VS or VC, though with few available studies for analysis. Conclusion In this heterogeneous cohort of prevalent KTR, vitamin K supplementation did not reduce VS or VC over 1 year. Improving vascular health in patients with established kidney disease is likely to require a multifaceted approach.

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