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

Renal Function Disorder Clinical Trial

Official title:

Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients——A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255020
• Other study ID #: KAPDRRF
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: May 20, 2015
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 an important determinant of mortality and morbidity in PD patients.

Previous studies have suggested that dietary protein restriction supplemented with α-keto acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are small sample and short-time research. In PD patients, there is very few reports to indicate the effect of α-keto acid with restricted protein diet on RRF.

The aim of this study is to 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.This is a prospective, double blind randomized, parallel control, and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group will use compound α-Keto Acid plus restricted protein diet, while control group will use placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted protein diet on RRF will be evaluated after 1 year treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Function Disorder
• Renal Insufficiency

Intervention

Drug:
• a-Keto Acid with restricted protein diet
a-Keto Acid: The daily dose of compound a-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day. Restricted Protein Diet: Diet contain protein 1.0g/kg/d
• Placebo plus restricted protein diet
placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day. Diet contain protein 1.0 g/kg/d.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	GuangZhou	Guangdong

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal change in residual glomerular filtration rate (GFR)		Every 3 months up to 12 months	Yes
Secondary	Peritoneal membrane transport characteristics		Every 3 months up to 12 months	Yes
Secondary	Cardiovascular events		Every 3 months up to 12 months	Yes
Secondary	Nutritional status		Every 3 months up to 12 months	Yes
Secondary	Hospitalization		Every 3 months up to 12 months	Yes