Effect of Oxalate and Urate Metabolism on CKD Evolution
关键词
抽象
描述
The study protocol is approved by a local Ethics Committee and registered in Domestic Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from all subjects participating in the study.
The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy subjects). Routine biochemical parameters including blood and daily dialysate concentration of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples, as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure in serum, urine and dialysate of peritoneal dialysis patients.
The study will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis dose, and so on. The outcomes will be analyzed using statistical software.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/18/2020 |
| 提交的预估入学人数: | 05/18/2020 |
| 首次发布: | 05/21/2020 |
| 上次提交的更新: | 05/18/2020 |
| 最近更新发布: | 05/21/2020 |
| 实际学习开始日期: | 01/09/2019 |
| 预计主要完成日期: | 11/30/2021 |
| 预计完成日期: | 11/30/2024 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Hyperoxalemia/Hyperuricemia Group | |
| Hyperoxalemia/Hyperuricemia-free Group | |
| Healthy Subjects |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - age >18 years old, - CKD stage 1-4, - the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or: - dialysis treatment for at least 3 months, - a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access, - a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients). Exclusion Criteria: - hospitalization in the preceding 3 months, - previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis. |
结果
主要结果指标
1. Renal Survival for CKD stages 1-3 [3 years]
次要成果指标
1. Cardio-vascular Events [3 years]
