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The goal of this clinical trial is to assess whether Amino Acid (15) Peritoneal Dialysis Solution can improve the nutritional status of adults with end-stage kidney disease who have received peritoneal dialysis for 6 months or longer. It will also observe the solution's effects on dialysis adequacy and peritoneal transport function, as well as monitor its short-term safety. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino Acid (15) PD Solution for Nutritional Support | Experimental | All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amino acid (15) peritoneal dialysis solution | Drug | Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Albumin (Alb) | At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 10, 2025 |
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This is a single-arm study with a self-controlled before-and-after design and no grouping. All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch.
The study will compare each participant's baseline health indicators (collected on the enrollment day) with those measured after 6 months of intervention to evaluate the efficacy and short-term safety of the intervention. No control group is included, as the comparison is conducted within the same participants to eliminate inter-individual confounding factors.
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| Jan 18, 2026 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D015314 | Dialysis Solutions |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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