The Modification of Diet in Renal Disease Study

• Status: Completed
• Trial end date: 2000-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: The Cleveland Clinic
• Treatments: Benzocaine

Criteria

Inclusion Criteria:

• Increased serum creatinine: Men: 1.4-7.0 mg/dl, Women: 1.2-7.0 mg/dl, or other objective evidence of kidney disease

• Mean arterial blood pressure <=125 mm Hg

• GFR 13-55 ml/min/1.73 m^2

• Urinary protein excretion <10 g/day

• Protein intake >0.90 g/kg/day if GFR 25-55 ml/min/1.73 m^2

Exclusion Criteria:

• Insulin-dependent diabetes or fasting serum glucose >200 mg/dl

• Patient on dialysis

• Kidney transplant recipient

• Lactating or pregnant woman or woman planning to become pregnant within the time frame of the study

• Doubtful compliance

• Body weight <80% or >160% of standard body weight

• Serum albumin <3.0 g/dl

• Selected renal disorders: Upper or lower urinary tract obstruction, Renal artery stenosis, Branched or staghorn calculi, Cystinuria

• Serious medical conditions: Malignancy (excluding skin cancer) within 1 year, Heart failure, New York Heart Association class 3 or 4, Lung disease, Liver disease, Gastrointestinal disease, Chronic systemic infections, including AIDS, Collagen vascular disease (other than rheumatoid arthritis), Frequent hospitalizations or disability

• Drugs: Immunosuppressive agents, Corticosteroids in excess of replacement dosage for 2 months per year or more, Gold or penicillamine within past month, Salicylates: more than 20 tablets per week, Other nonsteroidal antiinflammatory agents more than 3 times per week in past 2 months, Investigational drugs

• Allergy to iothalamate or iodine

• Inability or unwillingness to give consent