The Modification of Diet in Renal Disease Study

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.

Conditions

• Chronic Renal Disease

Interventions

OTHER

Usual Protein Diet

The usual protein diet contains 1.30 g/kg/day protein and 16-20 mg/kg/day of Phosphorus

OTHER

Low Protein Diet

The low protein diet contains 0.575 g/kg/day protein and 5-10 mg/kg/day of Phosphorus

OTHER

Very Low Protein Diet

The very low protein diet contains 0.28 g/kg/day or protein, mg/kg/day of Phosphorus and a keto acid mixture.

DRUG

Medications needed to maintain usual blood pressure

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.

DRUG

Medications needed to maintain low blood pressure

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.

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Gerald J Beck · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1989-01-01

Primary Completion

1993-01-31

Completion

2000-12-31

FDA Drug

Yes