Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression (MDRD)

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Kidney Diseases, Chronic; Dietary Modification

Treatments: Behavioral: Usual protein and phosphorus diet; Behavioral: Low protein and phosphorus diet; Behavioral: Very low protein and phosphorus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03202914

K01DK107782 (U.S. NIH Grant/Contract)

IRB00007383

Details and patient eligibility

About

The present record represents a secondary data analysis of the Modification of Diet in Renal Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of dietary intake as well as biomarkers of kidney disease progression.

Full description

The present study was conducted in order to: 1) quantify the metabolomic expression of dietary intake; and 2) examine the relationship between metabolites that reflect dietary intake and kidney disease progression. This secondary data analysis leverages the completed Modification of Diet in Renal Disease (MDRD) study, a randomized clinical trial of dietary protein restriction (N=840).

Enrollment: 840 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70
• Evidence of chronic renal disease with increased serum creatinine (men: 1.4-7.0 mg/dL, women: 1.2-7.0 mg/dL)
• Mean arterial blood pressure less than or equal to 125 mmHg

Exclusion criteria

• Insulin-dependent diabetes
• Kidney transplant recipient

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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840 participants in 3 patient groups

Usual protein and phosphorus diet

Active Comparator group

Description:

protein: 1.3 g/kg/day, phosphorus: 16-20 mg/kg/day

Treatment:

Behavioral: Usual protein and phosphorus diet

Low protein and phosphorus diet

Active Comparator group

Description:

protein: 0.58 g/kg/day with ≥0.35 g of protein high in amino acids, phosphorus: 5-10 mg/kg/day

Treatment:

Behavioral: Low protein and phosphorus diet

Very low protein and phosphorus

Experimental group

Description:

protein: 0.28 g/kg/day, phosphorus: 4-9 mg/kg/day; keto-acid and amino acid supplement (0.28 g/kg/day)

Treatment:

Behavioral: Very low protein and phosphorus