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

Primary Purpose

Dietary Modification, Kidney Diseases, Chronic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual protein and phosphorus diet

Low protein and phosphorus diet

Very low protein and phosphorus

About this trial

This is an interventional prevention trial for Dietary Modification

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Usual protein and phosphorus diet

Low protein and phosphorus diet

Very low protein and phosphorus

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum metabolomic profile

Metabolites were measured using a global, untargeted, metabolomic platform in serum specimens collected at the 12 month follow-up visit in the MDRD Study. Reverse phase, untargeted ultra-performance liquid chromatography tandem mass spectrometry quantification was used to measure metabolites. Peaks were quantified by calculating the area under the curve. Data were normalized to account for day-to-day instrumental variation. Compounds were identified by comparison to a library of purified standards or recurrent unknown entities and matches were determined based on retention time, mass-to-charge ratio, and chromatographic data.

Secondary Outcome Measures

Full Information

NCT ID

NCT03202914

First Posted

June 23, 2017

Last Updated

June 26, 2017

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03202914

Brief Title

Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

Acronym

MDRD

Official Title

Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression: A Secondary Data Analysis of the Modification of Diet in Renal Disease (MDRD) Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

October 1988 (Actual)

Primary Completion Date

May 1993 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dietary Modification, Kidney Diseases, Chronic

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The present study consists of a secondary data analysis of the MDRD Study. Planned analyses will be limited to participants with available stored specimens. The original MDRD Study was a 2 x 2 factorial study design, in which individuals were randomized to amounts of protein and phosphorus intake and levels of blood pressure control. In this secondary data analysis, we will analyze metabolites according to level of protein intake and will adjust for the blood pressure intervention.

Masking

Outcomes Assessor

Masking Description

During the original MDRD Study, clinical center personnel as well as study participants were masked to the results of the outcome assessment during the follow-up period.

Allocation

Randomized

Enrollment

840 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual protein and phosphorus diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Low protein and phosphorus diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Very low protein and phosphorus

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual protein and phosphorus diet

Intervention Description

Diet intervention

Intervention Type

Behavioral

Intervention Name(s)

Low protein and phosphorus diet

Intervention Description

Diet intervention

Intervention Type

Behavioral

Intervention Name(s)

Very low protein and phosphorus

Intervention Description

Diet intervention

Primary Outcome Measure Information:

Title

Serum metabolomic profile

Description

Time Frame

12 month follow-up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Casey M. Rebholz, PhD, MPH, MS

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bloomberg School of Public Health

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

8629624

Citation

Levey AS, Adler S, Caggiula AW, England BK, Greene T, Hunsicker LG, Kusek JW, Rogers NL, Teschan PE. Effects of dietary protein restriction on the progression of advanced renal disease in the Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1996 May;27(5):652-63. doi: 10.1016/s0272-6386(96)90099-2.

Results Reference

result

PubMed Identifier

8114857

Citation

Klahr S, Levey AS, Beck GJ, Caggiula AW, Hunsicker L, Kusek JW, Striker G. The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. Modification of Diet in Renal Disease Study Group. N Engl J Med. 1994 Mar 31;330(13):877-84. doi: 10.1056/NEJM199403313301301.

Results Reference

result

PubMed Identifier

30753252

Citation

Rebholz CM, Zheng Z, Grams ME, Appel LJ, Sarnak MJ, Inker LA, Levey AS, Coresh J. Serum metabolites associated with dietary protein intake: results from the Modification of Diet in Renal Disease (MDRD) randomized clinical trial. Am J Clin Nutr. 2019 Mar 1;109(3):517-525. doi: 10.1093/ajcn/nqy202.

Results Reference

derived

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Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

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