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The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients
The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No Intervention | Twice weekly hemodialysis program plus regular protein diet (1.0 g/kg/day) every day | |
| Ketosteril | Experimental | Incremental hemodialysis program, starting from once weekly hemodialysis/hemodialysis filtration(HDF) plus low protein diet (0.6 g/kg/day) and ketoanologues 0.12g/kg/day supplementation on non-dialysis days and regular protein diet (1.0-1.2 g/kg/day) on dialysis day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketosteril | Drug | ketoanalogues of essential amino acid |
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| Measure | Description | Time Frame |
|---|---|---|
| residual renal function | To demonstrate superiority effect of incremental hemodialysis (HD) protocol (initiate with once-weekly hemodialysis) plus ketoanalogues-supplemented low-protein diet during non-dialysis days over the standard HD protocol (initiate with twice weekly hemodialysis) on preservation of residual renal function (renal urea clearance) at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| visceral protein | To compare serum albumin levels between the two treatment groups over 12 months. | 12 months |
| structural protein | To compare muscle mass between the two treatment groups over 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C048995 | ketosteril |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| 12 months |
| muscle function | To compare muscle strength between the two treatment groups over 12 months. | 12 months |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |