Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design
研究概览
简要总结
This is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers.
The study will enroll fourty patients on regular 4-h three times per week hemodialysis (HD) of the dialysis unit of the "Fondazione IRCCS Policlinico San Matteo" (Pavia, Italy). Thirteen age and sex matched healthy individuals (Ctr) and ten CKD patients on peritoneal dialysis treatment (PD*) will be included as healthy and CKD-matched controls, respectively. Comparison between HD and PD patients is aimed to assess the effect of biocompatibility and protein leakage during the treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Male or female adults at time of enrolment aged <90 years old and >18 years old
- •Patients in stable standard bicarbonate HD regimen, for at least two months
排除标准
- •Patients aged <18 years old and >90 years old
- •Known hypersensitivity or allergy to class of drugs or the investigational product or inability to comply with the requirements of the protocol;
- •Participation in another study with investigational drug within the 30 days preceding and during the present study;
- •Enrolment of the investigator, his/her family members, employees and other dependent persons;
- •Recent illness (within the previous 1 week);
- •Severe anemia (Hb < 7 g/dl);
- •Bacterial or viral active infections;
结局指标
主要结局
Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design
时间窗: up to 24 months
次要结局
- Identification of plasma proteins composition of the uremic retentates.(day 0, day 90, day 180)
- Study on transcription factors alternative to Nrf2(day 0, day 90, day 180)
- Pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes.(day 0, day 90, day 180)
- Proteomics studies of the role of GSTP hyperexpression in the modulation of Nrf2 expression and activity in uremic leukocytes.(day 0, day 90, day 180)
- Study of Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes(day 0, day 90, day 180)
- Study of cell death in PBL freshly isolated from study groups(day 0, day 90, day 180)
- Determination of lymphocyte subpopulations ex vivo(day 0, day 90, day 180)
- Pathway analysis of the differentially expressed proteins of PBL and of principal component of complement system(day 0, day 90, day 180)
- Analysis of HMWs characteristic oxidative PTMs in plasma and PBL lysate samples collected(day 0, day 90, day 180)
- Analysis of CD4+ cells from blood samples and assessment of inflammatory cytokines after LPS stimulation(day 0, day 90, day 180)
研究者
Carmelo Libetta
Carmelo Libetta
Fondazione IRCCS Policlinico San Matteo di Pavia