The Modification of Diet in Renal Disease Study
Condition: Chronic Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The Modification of Diet in Renal Disease Trial is a multicenter randomized clinical trial
      for men and women aged 18-70 years with chronic renal disease who are not on dialysis and who
      have not had a kidney transplant. Study participants are randomized in a 2 × 2 factorial
      design to diets containing different amounts of protein and phosphorus and to two levels of
      blood pressure control. The prescribed modifications differ depending on the level of a
      patient's kidney function. The primary outcome variable to compare diet or blood pressure
      groups is each patient's slope (or the change) in glomerular filtration rate (GFR) with time.
    

Detailed description: 
      Selection of patients is conducted in two periods: a screening period for initial
      determination of eligibility and a 3-month baseline period. The baseline period is used to
      instruct patients about study procedures; to assess GFR and dietary protein intake; and to
      control blood pressure according to standard medical practice. GFR, dietary protein, and
      urinary protein must meet the eligibility criteria at the end of the baseline period before
      an individual can be randomized.

      Two different strata or studies are used depending on the level of an individual's GFR at the
      end of the baseline period. Study A is for individuals with a GFR from 25 to 55 ml/min/1.73
      m^2 and a usual dietary protein intake of at least 0.90 g/kg/day, where kg are standard body
      weight. Study B is for persons with a baseline GFR from 13 to 24 ml/min/1.73 m^2 and no
      specification of protein intake.

      Individuals who are randomized in the trial are prescribed one of three diets and one of two
      target mean arterial blood pressure goals (MAP). MAP is a weighted average of the diastolic
      and systolic blood pressures (two-thirds diastolic plus one-third systolic). The goals depend
      on the person's age. The moderate goal of 107 mm Hg is equivalent to a blood pressure of
      140/90 mm Hg, the usual limits of normal blood pressure. The low-MAP goal of 92 mm Hg is a
      more strict level of control than usually achieved, equivalent to, for example, 125/75 mm Hg.
    

Intervention name(s): Usual Protein Diet; Low Protein Diet; Very Low Protein Diet; Medications needed to maintain usual blood pressure; Medications needed to maintain low blood pressure
Intervention type(s): Other; Other; Other; Drug; Drug
Intervention description(s): The usual protein diet contains 1.30 g/kg/day protein and 16-20 mg/kg/day of Phosphorus; The low protein diet contains 0.575 g/kg/day protein and 5-10 mg/kg/day of Phosphorus; The very low protein diet contains 0.28 g/kg/day or protein, mg/kg/day of Phosphorus and a keto acid mixture.; The MAP goal for the usual blood pressure group is <=107 mm Hg for ages 18-60 and <=113 for ages 61+. Pharmacological and non-pharmacological therapies will be used to achieve the desired blood pressure values. The recommended anti-hypertensive regimen is a angiotensin-converting-enzyme inhibitor with or without a diuretic agent; a calcium-channel blocker or other medications can be added as needed.; The MAP goal for the low blood pressure group is <=92 mm Hg for ages 18-60 and <=98 for ages 61+. Pharmacological and non-pharmacological therapies will be used to achieve the desired blood pressure values. The recommended anti-hypertensive regimen is a angiotensin-converting-enzyme inhibitor with or without a diuretic agent; a calcium-channel blocker or other medications can be added as needed.
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment