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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)

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00363987
First received: August 13, 2006
Last updated: September 1, 2010
Last verified: August 2010

August 13, 2006
September 1, 2010
May 2006
December 2008   (final data collection date for primary outcome measure)
changes in urine protein and GFR [ Time Frame: one year ] [ Designated as safety issue: No ]
changes in urine protein and GFR
Complete list of historical versions of study NCT00363987 on ClinicalTrials.gov Archive Site
  • BMI(body mass index) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Blood albumin and prealbumin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Plasma High sensitivity C-reactive protein level [ Time Frame: one year ] [ Designated as safety issue: No ]
  • plasma lipids [ Time Frame: one year ] [ Designated as safety issue: No ]
nutritional indices (blood branched chain amino acids, BMI, blood albumin and prealbumin, SGA), High sensitivity CRP, blood lipids (cholesterol, triglyceride, HDL-C, LDL-C), fasting plasma
Not Provided
Not Provided
 
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)
A Multicenter, Randomized, Open-label, Parallel-group, Diabetic Diet-controlled Study to Evaluate the Efficacy and Safety of Compound α-Keto Acid Tablet in Combination With LPD in Delaying the Progress of Type 2 Diabetic Nephropathy

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.

Diabetic nephropathy is the most common cause for end-stage renal disease (ESRD) in Europe and America, which is directly related to rising incidence of type 2 diabetes. In addition, life lengthening of diabetic patients and ESRD patients receiving regular therapy are also important cause. According to data in the year of 1977, 40% of newly diagnosed ESRD patients in USA were caused by diabetes. Duo to enormous number and incessant increasing incidence of type 2 diabetic patients, type 2 diabetic nephropathy patients have already accounted for considerable proportion in the diabetic nephropathy patients who need dialysis. Recently in China the incidence of type 2 diabetes shows a tendency to escalate. It is expected that the number of diabetic patients will be up to 32 million in 2010.

α-Keto Acid is a product of amino acid deamination. Because it is nonnitrogenous and can accept amino to turn into the corresponding amino acid through transaminase in the body of patient with chronic renal failure, α-Keto Acid can reduce nitrogen supply, decrease urea production, stimulate protein synthesis, suppress protein decomposition, while offering adequate essential amino acids for body. Furthermore, α-Keto Acid and branched chain amino acids do not stimulate glucagon secretion and glucagon-induced cAMP secretion in liver, has no stimulating effect on hyperfiltration, thus contribute to delaying the progress of nephropathy.

It is extensively accepted that limited intake of diet protein to reduce kidney hyperfiltration and renal glomerulus internal pressure is effective in delaying the progress of nephropathy. But at present, debate exists in clinical research papers (such as MDRDS) to the role of low protein diet in delaying the progress of nephropathy. Adding compound α-Keto Acid tablet to low protein diet for patients can prevent essential amino acid deficiency and ameliorate severity of metabolism disorder, thus prevent malnutrition. Compared with standard diabetic diet, the aim of this study is to evaluate the efficacy and safety of compound α-Keto Acid tablet in combination with low protein diet in delaying the progress of nephropathy.

This is a multicentre, randomized, open-label, parallel group, diabetic diet controlled study. 240 patients who meet Inclusion/Exclusion criteria will be randomized into test groups or control groups at the ratio of 1:1. Test group will use low protein diet in combination with compound α-Keto Acid tablet, while control group will use routine diabetic diet, efficacy and safety of test group will be compared with those of control group after 1 year treatment. The study will be performed at 12 centres to ensure that at least 200 evaluable subjects are obtained.

STUDY OBJECTIVES:

  • To compare the efficacy (ameliorating proteinuria and kidney injury) of compound α-Keto Acid tablet in combination with low protein diet with that of standard diabetic diet in delaying the progress of type 2 diabetic nephropathy.
  • To compare the safety of compound α-Keto Acid tablet in combination with low protein diet with that of standard diabetic diet in delaying the progress of type 2 diabetic nephropathy.

Primary Endpoint: one year of treatment with Low Protein Diet plus α-Keto Acid or Diabetic Diet; Secondary Endpoint: Death, Dialysis or renal transplantation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Nephropathy
  • Drug: Ketosteril®
    1 tablet Ketosteril/5kgBW/d
  • Other: diabetic diet
    Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d
  • Experimental: 1
    Intervention: Drug: Ketosteril®
  • 2
    Intervention: Other: diabetic diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
June 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00363987
BFP503
Not Provided
Naidan Luo/medical manager, Beijing Fresenius Kabi Pharmaceutical Co
Fresenius Kabi
Not Provided
Principal Investigator: Shantan Lin Shanghai Huashan Hospital
Fresenius Kabi
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP