Status:
COMPLETED
Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Beijing Fresenius Kabi Pharmaceutical Co
Conditions:
Renal Function Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ren...
Detailed Description
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is ...
Eligibility Criteria
Inclusion
- Patients on peritoneal dialysis (PD) at least three month prior to study entry.
- Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
- Residual GFR ≥ 3 ml/min/1.73m2.
- Without α-Keto Acid therapy in recent 4 weeks.
- Subjects who agree to participate in the study and sign the informed consent.
Exclusion
- History of peritonitis or other infection within one month.
- Patients with insufficient dialysis.
- History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).
- Patients with diseases which contraindicate ketosteril.
- Cannot control diet according to protocol.
- Alcohol abuse or drug abuse.
- Having malignant tumor.
- History of psychiatric or neuropathic dysfunction.
- 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)
- Serum albumin \< 30g/l.
- Serum calcium \> 2.8mmol/l.
- Participation in another clinic trial within last three months
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01255020
Start Date
March 1 2010
End Date
December 1 2013
Last Update
May 22 2015
Active Locations (1)
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1
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080