Arterial pH and Total Body Nitrogen Balances in APD

Completed · Phase 4

Conditions studied: End-stage Renal Disease

In brief

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.

Key facts

Study ID

NCT00586131

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

8

Starts

2003-09-01

Expected to finish

2008-04-01

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• D/P Cr between 0.48 and 0.81 on the PET performed at the time of the screen.
• Total (renal + peritoneal) weekly Kt/V urea > 1.70 and creatinine clearance > 50 L/wk/1.73 m2.
• No evidence of primary or secondary (viz., ischemic, neuropathic) myopathy

You may not qualify if…

• 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.
• Insulin requiring diabetes mellitus.
• Patients who received L-carnitine or anabolic hormones (other than erythropoietin) within the previous 6 months.
• Use of CaCO3 as phosphate binder.
• Severe lung or liver disease, uncontrolled asthma, active vasculitis.
• Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses (e.g., active tuberculosis, AIDS, osteomyelitis).
• Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol.
• Alcohol or other recreational drug abuse.
• Pregnancy (rare in CPD patients).
• Patients who are physically and/or psychologically incapable of undergoing the protocol.

Where it is running

• Los Angeles Biomedical Research Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

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