Trial Outcomes & Findings for Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD (NCT NCT01128179)
NCT ID: NCT01128179
Last Updated: 2021-06-09
Results Overview
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
12 Weeks
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Lanthanum Carbonate
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
12
|
|
Overall Study
COMPLETED
|
21
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Lanthanum Carbonate
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
Baseline characteristics by cohort
| Measure |
Lanthanum Carbonate
n=23 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
69.4 years
STANDARD_DEVIATION 13.2 • n=107 Participants
|
67.2 years
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
Age, Customized
>=18 years
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
|
4.0089 pg/ml
Standard Error 0.0709
|
4.1210 pg/ml
Standard Error 0.0844
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
|
1.67 pg/ml
Standard Error 3.96
|
-4.87 pg/ml
Standard Error 4.72
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
|
-1.75 pg/ml
Standard Error 3.22
|
-6.86 pg/ml
Standard Error 3.85
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
|
-5.9 percentage of excretion of phosphate
Standard Error 1.5
|
-2.2 percentage of excretion of phosphate
Standard Error 1.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
|
0.0053 mmol/L
Standard Error 0.0371
|
0.0350 mmol/L
Standard Error 0.0443
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
|
0.0242 mmol/L
Standard Error 0.0323
|
-0.0052 mmol/L
Standard Error 0.0385
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: PP
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 Participants
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
|
0.0581 mmol^2/L^2
Standard Error 0.0833
|
0.0710 mmol^2/L^2
Standard Error 0.0993
|
Adverse Events
Lanthanum Carbonate
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanthanum Carbonate
n=23 participants at risk
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 participants at risk
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
4.3%
1/23
|
0.00%
0/12
|
|
Cardiac disorders
Myocardial ischemia
|
4.3%
1/23
|
0.00%
0/12
|
|
Gastrointestinal disorders
Pancreatitis acute
|
4.3%
1/23
|
0.00%
0/12
|
Other adverse events
| Measure |
Lanthanum Carbonate
n=23 participants at risk
1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
|
Placebo
n=12 participants at risk
Matching placebo chewable tablets administered 3 times a day for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER