Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)

NCT00363987 | Completed Phase 4

• 1 other identifier: BFP503
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of essential amino acids in the diet of diabetic nephropathy patients, along with restricted protein diets. This study is designed to explore whether alpha-Keto Acid supplementation with low protein diet will retard progression of type 2 diabetic nephropathy and also to assess effects of such supplemented diets on nutritional and other parameters in this patient group.

Conditions

Diabetic Nephropathy

Keywords

nephropathy with type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• changes in urine protein and GFR

  one year

Secondary Outcomes (4)

• BMI(body mass index)

  one year

• Blood albumin and prealbumin

  one year

• Plasma High sensitivity C-reactive protein level

  one year

• plasma lipids

  one year

Study Arms (2)

1

EXPERIMENTAL

Drug: Ketosteril®

2

OTHER

Other: diabetic diet

Interventions

Ketosteril® DRUG

1 tablet Ketosteril/5kgBW/d

1

diabetic diet OTHER

Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d

2

Eligibility Criteria

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

You may qualify if:

• Age \< 75 years, regardless of sex;
• Final diagnosis of type 2 diabetes;
• Plasma glucose is under control (fasting plasma glucose\<10mmol/L, glycosylated hemoglobin\<8.0%) with oral glucose-lowering agents (confine to Repaglinide, α-glycosidase inhibitors, Gliquidone) and /or insulin;
• Even through RAS blocker (ACEI/ARB) is administrated at a fixed dose (the same as the starting dose, refer to appendix 4) for more than 6 weeks, blood pressure is still ≤ 160/90 mmHg;
• Patient is without dialysis and GFR is \<60ml/min/1.73m2;
• Overt proteinuria is present two times within 2 weeks (urine albumin \> 300mg/d in a 24-h collection)

You may not qualify if:

• Diabetic ketoacidosis within the last 6 months;
• 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 within the last 3 months;
• With obvious symptoms or signs 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 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.

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

Shanghai Huashan Hospital

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

ketosteril; Diet, Diabetic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shantan Lin

  Shanghai Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: September 2, 2010

Record last verified: 2010-08

Locations

CN (1)