Trial Outcomes & Findings for Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients (NCT NCT00660530)
NCT ID: NCT00660530
Last Updated: 2020-11-03
Results Overview
measure of serum P concentration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Week 1-4 mean
Results posted on
2020-11-03
Participant Flow
Men and women at least 18 years of age, receiving hemodialysis (HD) for at least 3 months, with serum P concentrations \> 5.5 mg/dL at the end of the washout period, and on a stable dose of P binder and/or active vitamin D (if previously prescribed) for at least 1 month prior to the study were eligible for study participation.
Patients were excluded if they did not previously respond to P binder therapy, had a known non-compliance with oral medications, severe hyperparathyroidism defined as intact-PTH (i-PTH) \> 500 pg/ml, were taking any calcium-, magnesium- or aluminum-containing antacids or used an investigational agent within 30 days of study entry.
Participant milestones
| Measure |
Chewed or Crushed Lanthanum Carbonate
Lanthanum carbonate 1 g to be chewed or crushed, three times daily with meals, after 1-week washout period, then Lanthanum carbonate 1 g to be chewed crushed, three times daily with meals (the treatment that the subject did not receive in the initial treatment).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Chewed or Crushed Lanthanum Carbonate
n=11 Participants
Lanthanum carbonate 1 g to be chewed or crushed, three times daily with meals
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1-4 meanmeasure of serum P concentration
Outcome measures
| Measure |
Chewed Lanthanum Carbonate
n=11 Participants
Lanthanum carbonate 1 g to be chewed, three times daily with meals
|
Crushed Lanthanum Carbonate
n=11 Participants
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
Lanthanum carbonate: Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
|
|---|---|---|
|
Serum Phosphorous Concentration
|
2.0 mg/dL
Standard Error 0.5
|
1.7 mg/dL
Standard Error 0.4
|
Adverse Events
Chewed Lanthanum Carbonate
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Crushed Lanthanum Carbonate
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chewed Lanthanum Carbonate
n=11 participants at risk
Lanthanum carbonate 1 g to be chewed, three times daily with meals
|
Crushed Lanthanum Carbonate
n=11 participants at risk
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
|
|---|---|---|
|
Gastrointestinal disorders
Severe Constipation
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Severe Diarrhea
|
0.00%
0/11 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
Other adverse events
| Measure |
Chewed Lanthanum Carbonate
n=11 participants at risk
Lanthanum carbonate 1 g to be chewed, three times daily with meals
|
Crushed Lanthanum Carbonate
n=11 participants at risk
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • 4 weeks for each cross-over period
non-systematic assessment
|
18.2%
2/11 • Number of events 2 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
0.00%
0/11 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 4 weeks for each cross-over period
non-systematic assessment
|
0.00%
0/11 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Abdominal distension
|
18.2%
2/11 • Number of events 2 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
|
Vascular disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
9.1%
1/11 • Number of events 1 • 4 weeks for each cross-over period
non-systematic assessment
|
Additional Information
Dr. Alan Lau
University of Illinois College of Pharmacy
Phone: (312) 996-0894
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place