Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The prospective, double blind randomized, parallel control, and multi-center clinical trial will evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Beijing Fresenius Kabi Pharmaceutical Co

Criteria

Inclusion Criteria:

1. Patients on peritoneal dialysis (PD) at least three month prior to study entry.

2. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.

3. Residual GFR ≥ 3 ml/min/1.73m2.

4. Without α-Keto Acid therapy in recent 4 weeks.

5. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. History of peritonitis or other infection within one month.

2. Patients with insufficient dialysis.

3. History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).

4. Patients with diseases which contraindicate ketosteril.

5. Cannot control diet according to protocol.

6. Alcohol abuse or drug abuse.

7. Having malignant tumor.

8. History of psychiatric or neuropathic dysfunction.

9. Cardiac failure, with New York Heart Association (NYHA) grade III-IV or history of severe heart and cerebrovascular disease in recent one month(acute stroke, acute heart failure, Lability angina)

10. Serum albumin < 30g/l.

11. Serum calcium > 2.8mmol/l.

12. Participation in another clinic trial within last three months