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

NCT01255020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-05-22

No results posted yet for this study

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

Interventions

DRUG

α-Keto Acid with restricted protein diet

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

DRUG

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.

Sponsors & Collaborators

  • Beijing Fresenius Kabi Pharmaceutical Co

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xueqing YU, M.D. & Ph.D. · 1st Affiliated Hospital, Sun Yat-Sen University

  • Lan Chen, M.D. & Ph.D · Ruijin Hospital

  • Jianghua Chen, M.D. & Ph.D · First Affiliated Hospital of Zhejiang University

  • Zhangsuo Liu, M.D. & Ph.D · The First Affiliated Hospital of Zhengzhou University

  • Fei Xiong, M.D. · Wuhan Chinese and Western Medicine Combined Hospital

  • Qinfeng Han, M.D.&Ph.D · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01255020 on ClinicalTrials.gov