CompletedPhase 4

Arterial pH and Total Body Nitrogen Balances in APD

United States8 participantsStarted 2003-09

Plain-language summary

This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women from any ethnic/racial group \< 65 years.
. Treatment with CPD for 6 months and current treatment with APD for at least one month.
. Hemoglobin of at least 11.0 g/dl.
. Stable dose of erythropoietin treatment for at least the preceding three months.
. Subjects with normal nutritional status to mild malnutrition:
. Serum albumin \> 3.3 g/dl
. Relative body weight of 90-120% of the NHANES II median body weight for a given height, age range, gender and frame size.
. A normalized protein equivalent of total nitrogen appearance (nPNA) \> 0.80 g/kg actual body weight/day at the time of screening.

Exclusion criteria

. History of active cancer other than basal cell carcinoma.
. Symptomatic severe ischemic heart disease, uncontrolled severe dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputation of the lower extremities.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

N-balances

Timeframe: 20 days

Trial details

NCT IDNCT00586131

SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

View on ClinicalTrials.gov More End-stage Renal Disease trials