Trial Outcomes & Findings for FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease (NCT NCT00999037)

NCT ID: NCT00999037

Last Updated: 2023-05-31

Results Overview

Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-05-31

Participant Flow

Participant milestones

Measure	Renvela Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks	Placebo Placebo (inert tablets): 1 tablet TID with meals for 12 weeks
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Renvela n=9 Participants Daily renvela with meals for 12 weeks Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks	Placebo n=9 Participants Placebo: 1 inert tablet tid x 12 weeks	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.3 years STANDARD_DEVIATION 3.2 • n=5 Participants	15.4 years STANDARD_DEVIATION 4.6 • n=7 Participants	14.3 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.

Outcome measures

Measure	Renvela n=9 Participants Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks	Placebo n=9 Participants Placebo (1 inert tablet) PO TID with meals x 12 weeks
Change in FGF-23 Level	16 percentage change from baseline Standard Deviation 41	41 percentage change from baseline Standard Deviation 46

SECONDARY outcome

Timeframe: 12 week

Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.

Outcome measures

Measure	Renvela n=9 Participants Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks	Placebo n=9 Participants Placebo (1 inert tablet) PO TID with meals x 12 weeks
1,25(OH)2vitamin D Value	82 percent change from baseline Standard Deviation 64	69 percent change from baseline Standard Deviation 82

SECONDARY outcome

Timeframe: 12 weeks

Change in serum phosphate at 12 weeks from baseline

Outcome measures

Measure	Renvela n=9 Participants Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks	Placebo n=9 Participants Placebo (1 inert tablet) PO TID with meals x 12 weeks
Serum Phosphate Concentration	-4 percent change from baseline Standard Deviation 46	-8 percent change from baseline Standard Deviation 49

Adverse Events

Renvela

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Katherine Wesseling-Perry

University of California at Los Angeles

Phone: 310-206-6987

Email: kwesseling@mednet.ucla.edu

Results disclosure agreements

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