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A Study on Amino Acid Peritoneal Dialysis Solution for Improving Nutrition in Peritoneal Dialysis Patients

Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status of Peritoneal Dialysis Patients: A Single-Center, Prospective, Open-Label, Before-After Self-Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118624
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease (ESRD)

Interventions

Amino Acid Dialysis Group:Amino Acid (15) Peritoneal Dialysis Solution

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, undergoing peritoneal dialysis treatment for >=6 months; 2. Serum albumin level 1 year; 6. Good compliance and willingness to sign the informed consent form; 7. Diagnosed with end-stage renal disease (ESRD) with estimated glomerular filtration rate (eGFR) < 15 mL/ (min·1.73 m²).

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity 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; 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.

Design outcomes

Primary

MeasureTime frame
Nutritional status;

Secondary

MeasureTime frame
Prealbumin, Transferrin, Plasma and PD Ultrafiltrate Amino Acid Profile;Total Urea Clearance Index, Peritoneal Creatinine Clearance;Lean Body Mass;Subjective Global Assessment (SGA) Score;

Countries

China

Contacts

Public ContactWen Xue

Shanghai Tenth People's Hospital

xuewen1810668@126.con+86 21 66302527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026