Trial Outcomes & Findings for The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease (NCT NCT01002872)

Results Overview

Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline, 60 days

Results posted on

2023-09-21

Participant Flow

The date of recruitment 10/27/09-3/7/12.The subjects were seen at Evanston and Glenbrook outpatient clinics

Subjects who were naive to phosphate binders were enrolled

Participant milestones

Participant milestones
Measure	Lanthanum Carbonate (Fosrenol) Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lanthanum Carbonate (Fosrenol) n=10 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=9 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=7 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=6 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline	-62.96 RU/mL Standard Deviation 55.17	9.08 RU/mL Standard Deviation 53.84

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline Calcium level at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=8 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=8 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Calcium Mean Change From Baseline	0.15 mg/dL Standard Deviation 0.49	0.04 mg/dL Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline serum phosphate at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=8 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=8 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Serum Phosphate Mean Change From Baseline	0.18 mg/dL Standard Deviation 0.93	0.22 mg/dL Standard Deviation 0.54

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Change from baseline serum parathyroid hormone at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=8 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=8 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Change From Baseline Serum Parathyroid Hormone	-18.75 percent change in PTH Standard Deviation 25.91	-33.25 percent change in PTH Standard Deviation 117.70

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=4 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=5 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline	-1.25 ng/mL Standard Deviation 8.66	-12.20 ng/mL Standard Deviation 23.83

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline 25 hydroxyvitamin D at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=7 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=8 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
25 Hydroxyvitamin D Mean Change From Baseline	0.43 ng/mL Standard Deviation 6.16	2.00 ng/mL Standard Deviation 7.67

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline serum alkaline phosphatase at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=8 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=9 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
Serum Alkaline Phosphatase Mean Change From Baseline	-0.50 U/L Standard Deviation 4.51	-0.40 U/L Standard Deviation 1.91

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Osteocalcin concentrations were not measured

Mean change from baseline serum osteocalcin at 60 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 60 days

Population: Only patients with readings at both timepoints (baseline and 60 days) were included.

Mean change from baseline 24 hour urine phosphate at 60 days

Outcome measures

Outcome measures
Measure	Lanthanum Carbonate (Fosrenol) n=7 Participants Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=6 Participants Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
24 Hour Urine Phosphate Mean Change From Baseline	-148.6 mg Standard Deviation 64.3	5.2 mg Standard Deviation 78.7

Adverse Events

Lanthanum Carbonate (Fosrenol)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lanthanum Carbonate (Fosrenol) n=10 participants at risk Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill BID. If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner	Placebo n=9 participants at risk Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day
General disorders mild	10.0% 1/10 • Number of events 1 • 60 days	0.00% 0/9 • 60 days

Additional Information

Dr Stuart Sprague

Northshore University Healthsystem

Phone: 847-570-1761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place