Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients (NCT00660530) | Clinical Trial Compass
CompletedPhase 2
Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
United States11 participantsStarted 2008-01
Plain-language summary
Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to bind dietary phosphate and is effective in the management of hyperphosphatemia and in preventing secondary hyperparathyroidism.
Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the lanthanum carbonate tablets. For such patients, medications are commonly crushed and administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food will be as efficacious as chewing it.
The objective of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate in patients undergoing hemodialysis.
Who can participate
Age range
18 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:
* Male or female 18 years of age or older
* Have been on hemodialysis for at least 3 months
* Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative serum pregnancy test
* On a stable dose of phosphate binder for at least 1 month prior to the study
* On a stable dose of active vitamin D (if previously prescribed) for at least 1 month prior to the study
* Serum phosphorus concentrations \> 5.5 mg/dL (1.78 mmol/L) at the end of the washout period
Exclusion Criteria:
* Did not previously respond to phosphate binder therapy
* Known non-compliance with oral medications
* Severe hyperparathyroidism defined as intact-PTH (i-PTH) \> 500 pg/ml
* Taking any calcium-, magnesium- or aluminum-containing antacids
* Use of an investigational agent within 30 days of study entry
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.