End-stage Renal Disease (ESRD)Phase 4AA15-PD-Nut-SHNCT07370441
Amino Acid (15) Peritoneal Dialysis Solution for Nutritional Improvement in Peritoneal Dialysis Patients
A Phase 4 study testing amino acid (15) peritoneal dialysis solution in people with End-stage Renal Disease (ESRD) and Peritoneal Dialysis (PD), run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status
- What is being tested?
- amino acid (15) peritoneal dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Have received peritoneal dialysis for 6 months or longer.
- Serum albumin level < 38 g/L.
- No history of peritonitis in the past 3 months and no hospitalization in the past 1 month.
- No severe heart, liver, kidney diseases, or malignant tumors.
- Expected survival time > 1 year.
- Good compliance and willingness to sign the informed consent form.
- Diagnosed with end-stage renal disease (ESRD) with an estimated glomerular filtration rate (eGFR) < 15 mL/(min·1.73 m²).
Who cannot join
- Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
- Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
- Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
- Need for adjustment of nutritional supplement doses during the study.
- Uncorrectable severe gastrointestinal reactions.
- Pregnant, lactating, or planning to undergo kidney transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status in Peritoneal Dialysis Patients
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:
- Can Amino Acid (15) Peritoneal Dialysis Solution raise the level of serum albumin (a key indicator of nutritional status) in participants?
- How does this solution affect participants' dialysis adequacy and peritoneal transport function?
- What adverse reactions might participants experience when using this solution? This is a single-arm study with a self-controlled design. Researchers will compare participants' health indicators before and after the intervention to evaluate the solution's effectiveness and safety.
Read more
Participants will:
- Continue their original peritoneal dialysis routine, replacing one bag of dialysis solution with Amino Acid (15) Peritoneal Dialysis Solution (2L per bag) after lunch every day for 6 months.
- Undergo comprehensive health checks (including blood tests, nutritional status assessments, and peritoneal function evaluations) on the enrollment day (baseline), as well as at 3 and 6 months after the intervention.
- Attend follow-up visits every 2 weeks to record dialysis-related data (such as ultrafiltration volume) and any uncomfortable symptoms or adverse reactions.
- Maintain stable doses of medications affecting protein metabolism and nutritional supplements throughout the study; report to researchers immediately if any dose
- Conditions
- End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status, Renal Replacement Therapy
- Being tested
- amino acid (15) peritoneal dialysis solution
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid (15) peritoneal dialysis solutionDrug
Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: amino acid (15) peritoneal dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin (Alb)
Measured: At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Xue MD, PhD, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370441
- Sponsor's protocol ID
- SH10H-AA15-PD-Nutrition
- Acronym
- AA15-PD-Nut-SH
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided