Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

NCT00734552 | Completed DMC

• 1 other identifier: SYSU-KAPDRRF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.

Conditions

Peritoneal Dialysis

Keywords

Continuous Ambulatory Peritoneal Dialysis; α-Keto Acid; Low Protein Diet; Residual Renal Function

Outcome Measures

Primary Outcomes (1)

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

  Every 3 months

Secondary Outcomes (1)

• Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.

  Every 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

α-Keto Acid plus low protein diet

Dietary Supplement: α-Keto Acid with low protein diet

2

OTHER

Normal protein diet

Dietary Supplement: Normal protein diet

Interventions

α-Keto Acid with low protein diet DIETARY_SUPPLEMENT

Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day. Low Protein Diet: Diet contain protein 0.8g/kg/d.

Also known as: Test Group

1

Normal protein diet DIETARY_SUPPLEMENT

Diet contain protein 1.0-1.2 g/kg/d.

Also known as: Control Group

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on PD at least one month prior to study entry.
• Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
• Residual GFR ≥3 ml/min/1.73m2.
• Residual urine volume ≥ 500 ml/24h.
• No history of taking α-Keto Acid within 2 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.
• History of taking drug which may affect amino acid metabolism within one month.
• Incapable of following study requirements to control diet.
• With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
• Participation in another clinic trial within one month prior to screening.

Sponsors & Collaborators

• Sun Yat-sen University: lead

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2010
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

CN (1)