Trial Outcomes & Findings for Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy (NCT NCT01130831)

NCT ID: NCT01130831

Last Updated: 2021-06-28

Results Overview

Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

• Recruitment status: COMPLETED
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-06-28

Participant Flow

Participant milestones

Measure	Lanthanum Carbonate Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for \>=3 months.
Overall Study STARTED	66
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Lanthanum Carbonate Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for \>=3 months.
Overall Study Withdrawal by Subject	7
Overall Study Death	4
Overall Study Information was missing	3

Baseline Characteristics

Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy

Baseline characteristics by cohort

Measure	Lanthanum Carbonate n=61 Participants Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for \>=3 months.
Age, Continuous	66.0 years STANDARD_DEVIATION 12.5 • n=5 Participants
Age, Customized >=18 years	61 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment Germany	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=47 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy	14.9 percentage of subjects Interval 6.2 to 28.3

PRIMARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate	40.0 percentage of subjects Interval 24.9 to 56.7

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=47 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy	68.1 percentage of subjects Interval 52.9 to 80.9

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy	52.5 percentage of subjects Interval 36.1 to 68.5

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=47 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy	42.6 percentage of subjects Interval 28.3 to 57.8

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy	75.0 percentage of subjects Interval 58.8 to 87.3

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=42 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate <=1 quarter	73.8 percentage of subjects
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate 2 consecutive quarters	7.1 percentage of subjects
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate 3 consecutive quarters	7.1 percentage of subjects
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate 4 consecutive quarters	11.9 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=41 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate <=1 quarter	53.7 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate 2 consecutive quarters	22.0 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate 3 consecutive quarters	7.3 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate 4 consecutive quarters	17.1 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy <=1 quarter	47.5 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy 2 consecutive quarters	17.5 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy 3 consecutive quarters	5.0 percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy 4 consecutive quarters	30.0 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=38 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy <=1 quarter	81.6 percentage of subjects
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy 2 consecutive quarters	10.5 percentage of subjects
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy 3 consecutive quarters	2.6 percentage of subjects
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy 4 consecutive quarters	5.3 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in Phosphorous Levels at 12 Months	-7.9 percent change in phosphorous levels Standard Deviation 24.3

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in Calcium Levels at 12 Months	-1.1 percent change in calcium levels Standard Deviation 8.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months	-8.7 percent change in calcium-phosphorous Standard Deviation 26.5

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=32 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in iPTH Levels at 12 Months	95.4 percent change in iPTH levels Standard Deviation 393.4

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=6 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months	41.0 percent change in vitamin D Standard Deviation 48.6

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=4 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months	1.1 percent change in vitamin D Standard Deviation 28.6

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=47 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy	10.6 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate	22.5 percentage of subjects

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=47 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy	0.0 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Hypercalcemia defined as total serum calcium above 11.22 mg/dL

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=40 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate	0.0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=33 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Change From Baseline in Vitamin D Dose at 12 Months	-0.7 ng Standard Deviation 0.0075

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=6 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months	-178.6 mg Standard Deviation 437.6

SECONDARY outcome

Timeframe: 12 months

Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior

Outcome measures

Measure	Calcium-based Phosphate Binder Therapy n=35 Participants The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of \>=3 months of treatment prior to receiving lanthanum carbonate treatment.
Number of Tablets Per Day	3.4 Number of Tablets Standard Deviation 1.3

Adverse Events

Lanthanum Carbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

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