Trial Outcomes & Findings for A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia (NCT NCT01039428)

NCT ID: NCT01039428

Last Updated: 2015-09-14

Results Overview

Change in serum inorganic phosphorus at the end of treatment from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 68 participants
• Primary outcome timeframe: baseline and end of the chewing treatment during three week treatment period
• Results posted on: 2015-09-14

Participant Flow

Sixty eight HD patients maintained on calcium carbonate (33 subjects) or sevelamer (35 subjects) were enrolled during January - April, 2010. Sixty-three patients chewed at least one gum: 35 HS219 and 28 placebo.

Participant milestones

Measure	HS219 Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.	Placebo Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Overall Study STARTED	35	28
Overall Study COMPLETED	33	28
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	HS219 Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.	Placebo Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Baseline characteristics by cohort

Measure	HS219 n=35 Participants Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.	Total n=63 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	55.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	56.4 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and end of the chewing treatment during three week treatment period

Population: Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.

Change in serum inorganic phosphorus at the end of treatment from baseline

Outcome measures

Measure	HS219 n=35 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline	-0.26 mg/dL Standard Deviation 1.19	-0.20 mg/dL Standard Deviation 1.21

SECONDARY outcome

Timeframe: baseline and end of the treatment

Population: Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.

Outcome measures

Measure	HS219 n=35 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL	7 participants Interval 0.08 to 0.37	2 participants Interval 0.01 to 0.24

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Outcome measures

Measure	HS219 n=31 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=23 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3	8 participants Interval 0.12 to 0.45	2 participants Interval 0.01 to 0.28

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=33 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Serum Inorganic Phosphorus Level	6.38 mg/dL Standard Deviation 1.35	6.29 mg/dL Standard Deviation 1.29

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=32 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Salivary Inorganic Phosphorus Level	22.32 mg/dL Standard Deviation 8.04	21.51 mg/dL Standard Deviation 8.95

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=33 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])	9.37 mg/dL Standard Deviation 0.66	9.13 mg/dL Standard Deviation 0.61

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=33 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Ca×P	59.90 mg/mL*mg/mL Standard Deviation 13.87	57.24 mg/mL*mg/mL Standard Deviation 11.34

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=33 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Serum Intact Parathyroid Hormone (PTH) Level	206.5 pg/mL Standard Deviation 141.2	251.2 pg/mL Standard Deviation 183.6

SECONDARY outcome

Timeframe: week 3

Population: Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.

Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Outcome measures

Measure	HS219 n=33 Participants Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.	Placebo n=28 Participants Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
Serum Intact Fibroblast Growth Factor (FGF) 23 Level	4.0 log10(pg/mL) Standard Deviation 0.5	4.0 log10(pg/mL) Standard Deviation 0.5

Adverse Events

HS219

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HS219 n=35 participants at risk Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.	Placebo n=28 participants at risk Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Infections and infestations common cold	11.4% 4/35 • Number of events 21	7.1% 2/28 • Number of events 10
Gastrointestinal disorders queasy	5.7% 2/35 • Number of events 21	35.7% 10/28 • Number of events 10

Additional Information

Study Director

KDL

Phone: 818058844243

Email: toiawase@advance-cro.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60