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

NCT01255020 | Completed DMC

• 1 other identifier: KAPDRRF
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.

Conditions

Renal Function Disorder

Keywords

α-Keto Acid; Restricted Protein Diet; Residual Renal Function

Outcome Measures

Primary Outcomes (1)

• The longitudinal change in residual glomerular filtration rate (GFR)

  Every 3 months up to 12 months

Secondary Outcomes (4)

• Peritoneal membrane transport characteristics

  Every 3 months up to 12 months

• Cardiovascular events

  Every 3 months up to 12 months

• Nutritional status

  Every 3 months up to 12 months

• Hospitalization

  Every 3 months up to 12 months

Study Arms (2)

α-Keto Acid plus restricted protein diet

ACTIVE COMPARATOR

Participants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d.

Drug: α-Keto Acid with restricted protein diet

Placebo plus restricted protein diet

PLACEBO COMPARATOR

All participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d.

Drug: Placebo plus restricted protein diet

Interventions

α-Keto Acid with restricted protein diet DRUG

α-Keto Acid: The daily dose of compound α-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

Also known as: Test Group

α-Keto Acid plus restricted protein diet

Placebo plus restricted protein diet DRUG

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.

Also known as: Control Group

Placebo plus restricted protein diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Beijing Fresenius Kabi Pharmaceutical Co: collaborator

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Diet, Protein-Restricted; Control Groups

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xueqing YU, M.D. & Ph.D.

  1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Lan Chen, M.D. & Ph.D

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jianghua Chen, M.D. & Ph.D

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Zhangsuo Liu, M.D. & Ph.D

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Fei Xiong, M.D.

  Wuhan Chinese and Western Medicine Combined Hospital

  PRINCIPAL INVESTIGATOR

• Qinfeng Han, M.D.&Ph.D

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: December 7, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

CN (1)