Can a dialysis boost fix malnutrition in kidney patients?
NCT ID NCT07370441
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special dialysis fluid containing amino acids (protein building blocks) to see if it can improve the nutritional status of adults with end-stage kidney disease who are on peritoneal dialysis. About 50 participants will replace one daily dialysis bag with this solution for 6 months. Researchers will monitor blood protein levels, dialysis effectiveness, and any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or older. 2. Have received peritoneal dialysis for 6 months or longer. 3. Serum albumin level \< 38 g/L. 4. No history of peritonitis in the past 3 months and no hospitalization in the past 1 month. 5. No severe heart, liver, kidney diseases, or malignant tumors. 6. Expected survival time \> 1 year. 7. Good compliance and willingness to sign the informed consent form. 8. Diagnosed with end-stage renal disease (ESRD) with an estimated glomerular filtration rate (eGFR) \< 15 mL/(min·1.73 m²). Exclusion Criteria: 1. Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components. 2. Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal). 3. Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period. 4. Need for adjustment of nutritional supplement doses during the study. 5. Uncorrectable severe gastrointestinal reactions. 6. Pregnant, lactating, or planning to undergo kidney transplantation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
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Other studies related to the condition(s) this trial covers.
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