NCT01418508

Brief Summary

The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 3b and 4).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 17, 2011

Status Verified

August 1, 2011

Enrollment Period

3.3 years

First QC Date

August 15, 2011

Last Update Submit

August 16, 2011

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • changes in glomerular filtration rate

    1 year

Secondary Outcomes (4)

  • Compliance to diet

    1 year

  • Quality of life

    1 year

  • Cardiovascular morbidity

    1 year

  • Nutritional status

    1 year

Study Arms (3)

low protein diet

NO INTERVENTION

Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day

low protein diet plusα-keto acid

EXPERIMENTAL

0.6g of proteins per kilo of body weight per day

Behavioral: low protein diet plus α-keto acid

very low protein diet plus α-keto acid

EXPERIMENTAL

0.3g of proteins per kilo of body weight per day

Behavioral: very low protein diet plus α-keto acid

Interventions

low protein diet plus α-keto acidBEHAVIORAL

low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets

low protein diet plusα-keto acid
very low protein diet plus α-keto acidBEHAVIORAL

very low protein diet plus α-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets

very low protein diet plus α-keto acid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic kidney disease in stage 3b and 4(15ml/min/1.73m2\<GFR\<45 ml/min/1.73m2, estimated by EPI formula) receiving conservative treatment for CKD

You may not qualify if:

  • With diagnosis of diabetic mellitus;
  • Incapable of following study requirements to control diet;
  • Glomerular filtration rate \< 15 ml/min/1.73m2;
  • Hypercalcemia or hyperkalemia (\> normal upper limit);
  • Other serious disease(eg.heart,lung,brain) within the last 3 months;
  • Cardiac failure stage IV NYHA;
  • With cirrhosis of liver or obvious symptoms of liver diseases, ALT or AST two times normal upper limit;
  • Severe edema or serous cavity effusion;
  • Drug abuse;
  • Final diagnosis of malignant tumor;
  • Receiving the long-term systematic steroid hormone or immunosuppressive agents(eg. Cyclophosphamidum,Cyclosporine, Prograf,Azathioprine) treatment;
  • Gestation already, prepares to be pregnant in the period of the trial, lactating women;
  • Participate in other product clinical trial within 30 days prior to this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.

    PMID: 33118160DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Xuemei Li, M.D.& Ph.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuemei Li, M.D.& Ph.D.

CONTACT

8610-652950580605.mei@gmail.com

Limeng Chen, M.D.& Ph.D.

CONTACT

8610-65295351climeng2000@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 17, 2011

Record last verified: 2011-08

Locations

CN(1)