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)
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Ketosteril®; diabetic diet
Intervention type(s): Drug; Other
Intervention description(s): 1 tablet Ketosteril/5kgBW/d; Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nephropathy with type 2 diabetes