Dietary Phosphorus for Chronic Kidney Disease

(PACK Trial)

Overseen By Paola Lanza, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Insulin, Chemotherapy, Phosphate binders, others

Disqualifiers: Pregnancy, Dialysis, Smoking, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability.

Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability.

This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.

Who Is on the Research Team?

Jing Chen, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Kidney Disease (CKD), including those at risk of kidney failure or renal osteodystrophy. Participants should be interested in how their diet affects their health, specifically phosphate intake.

Inclusion Criteria

Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories

English speaking

My kidney function is reduced but not severely (Stage 3 or 4 CKD).

Exclusion Criteria

Smokes cigarettes or uses e-cigarettes (vapes)

I don't have uncontrolled thyroid, parathyroid disorders, severe gut issues, or cirrhosis affecting my phosphate levels.

I do not have a working fridge or freezer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants undergo a 21-day dietary intervention with varying phosphorus intake levels

3 weeks

Weekly visits for blood and urine sample collection

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing the effects of dietary phosphorus intake on CKD patients. It aims to discover new pathways in phosphate metabolism, identify biomarkers for phosphate overload, and develop a reliable index to measure dietary phosphorus intake.

How Is the Trial Designed?

Group I: Chronic Kidney Disease Patients Active Control 1 Intervention

Participants with eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group

Group II: Control Group Active Control 1 Intervention

Healthy participants without CKD eGFR ≥ 60 ml/min/1.73m2

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+