end-stage renal disease (ESRD)
Conditions
Interventions
investigational group:Renalive dialysis
control group:Fresubin 750MCT
Sponsors
Peking university first hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Consent to participate in the study with a signed and dated informed consent form (ICF) 2. Age between 18-80 years old 3. Patient with ESRD 4. Minimum of last 3 months on stable peritoneal dialysis (Regular peritoneal treatment for 3 months, Kt/V >1.5 within 3 months, with none or stable clinical symptoms, no expected renal transplantation, or other surgical procedures during the study. Patients are expected to have stable peritoneal dialysis (PD) total dosing and type of dialysate during study) 5. Serum albumin level <35 g/L, monitored twice within 3 months before the study start 6. Daily energy intake (DEI) <25 kcal/IBW/d and/or Daily protein intake (DPI) <1.0 g/kg IBW/d
Exclusion criteria
Exclusion criteria: 1. Patients on PD and receiving other types of renal replacement therapy (e.g., hemodialysis, hemofiltration, hemodiafiltration) at same time 2. Severe gastrointestinal (GI) diseases or contraindications for enteral nutrition, such as gastrointestinal hemorrhage, intestinal obstruction, severe dyspepsia. 3. Patients with malignant tumors who have received antitumor therapy within the last three years prior to study screening period. 4. Severe heart failure (New York Heart Association Functional Class >III), acute myocardial infarction, severe metabolic acidosis, uremic encephalopathy within 3 months prior to study screening period 5. Severe hepatic dysfunction associated with aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>5 Upper Limit of Normal(ULN) or total bilirubin(TBiL) >3 ULN 6. Acute infection (including Peritonitis), severe sepsis, septic shock, within 1 month prior to study screening period 7. Serious psychiatric disorder 8. Known HIV infection, active tuberculosis, active hepatitis B or C 9. Alcohol or drug abuse 10. Congenital inability to metabolize nutrients in the investigational and the control product 11. Use of parenteral or enteral nutrition within one month prior to study screening period 12. Use of amino acid containing dialysate within one month prior to study screening period 13. Known allergic reaction or intolerance to any ingredients of the investigational and control product 14. Pregnant or lactating women, women who plan pregnancy and do not consent to use contraception during trial 15. Participation in another clinical study with an investigational drug, FSMP or investigational medical device one month prior to the start of study or planned participation in another clinical trial during the study period 16. Patient who is unable to understand the spoken or written information or not willing or not able to comply with scheduled visits and the requirements of the study protocol 17. Considered not suitable for study participation by the investigator, i.e., any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardise the safety of the patient or affect the validity of the trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum prealbumin;Body weight;BMI;anthropometric parameters;the energy and protein intake based on dietary assessment between the treatment groups;blood urea nitrogen;serum creatinine;hs-CRP;serum electrolyte;blood glucose;blood lipids; | — |
Countries
China
Contacts
Public ContactJie Dong
Peking university first hospital
Outcome results
None listed