Effect of Oxalate and Urate Metabolism on CKD Evolution
キーワード
概要
説明
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.
日付
| 最終確認済み: | 04/30/2020 |
| 最初に提出された: | 05/18/2020 |
| 提出された推定登録数: | 05/18/2020 |
| 最初の投稿: | 05/21/2020 |
| 最終更新が送信されました: | 05/18/2020 |
| 最終更新日: | 05/21/2020 |
| 実際の研究開始日: | 01/09/2019 |
| 一次完了予定日: | 11/30/2021 |
| 研究完了予定日: | 11/30/2024 |
状態または病気
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Hyperoxalemia/Hyperuricemia Group | |
| Hyperoxalemia/Hyperuricemia-free Group | |
| Healthy Subjects |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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. |
結果
主な結果の測定
1. Renal Survival for CKD stages 1-3 [3 years]
二次的な結果の測定
1. Cardio-vascular Events [3 years]
