Status:
COMPLETED
The Modification of Diet in Renal Disease Study
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Chronic Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ...
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2000
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT04364113
Start Date
January 1 1989
End Date
December 31 2000
Last Update
April 27 2020
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