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Trial Outcomes & Findings for Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease (NCT NCT01191762)

NCT ID: NCT01191762

Last Updated: 2016-11-01

Results Overview

This outcome measure documented the effect of intestinal phosphate-binding on \[PTH\]. Fractional change was calculated as (\[PTH\]post - \[PTH\]pre)/\[PTH\]pre, where 'pre' and 'post' referred respectively to baseline \[PTH\] (before treatment) and \[PTH\] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-11-01

Participant Flow

Patients with eGFR \< 60 were recruited from renal clinics and randomized to receive 3 tablets of sevelamer or placebo with each meal for four weeks.

Randomization was preceded by a 4-week course of vitamin D (dose determined by plasma \[25OHD\]) and then by a 4-week period of dietary phosphate restriction. The phosphate restriction was continued through the therapeutic trial.

Participant milestones

Participant milestones
Measure
Sevelamer Carbonate
2400 mg (3 pills) with each meal sevelamer carbonate : 2400 mg with each meal for 4 weeks
Placebo Control
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. placebo : 3 tablets with each meal
Overall Study
STARTED
15
15
Overall Study
COMPLETED
14
15
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Sevelamer Carbonate
2400 mg (3 pills) with each meal sevelamer carbonate : 2400 mg with each meal for 4 weeks
Placebo Control
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. placebo : 3 tablets with each meal
Overall Study
Adverse Event
1
0

Baseline Characteristics

Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sevelamer Carbonate
n=14 Participants
2400 mg (3 pills) with each meal sevelamer carbonate : 2400 mg with each meal for 4 weeks
Placebo Control
n=15 Participants
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. placebo : 3 tablets with each meal
Total
n=29 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
3 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
9 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Continuous
73.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
70.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
71.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
15 participants
n=7 Participants
29 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

This outcome measure documented the effect of intestinal phosphate-binding on \[PTH\]. Fractional change was calculated as (\[PTH\]post - \[PTH\]pre)/\[PTH\]pre, where 'pre' and 'post' referred respectively to baseline \[PTH\] (before treatment) and \[PTH\] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.

Outcome measures

Outcome measures
Measure
Sevelamer Carbonate
n=14 Participants
2400 mg (3 pills) with each meal sevelamer carbonate : 2400 mg with each meal for 4 weeks
Placebo Control
n=15 Participants
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. placebo : 3 tablets with each meal
Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate
-11.7 percentage of baseline [PTH]
Standard Error 5.8
16.4 percentage of baseline [PTH]
Standard Error 10.0

Adverse Events

Sevelamer Carbonate

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo Control

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
Sevelamer Carbonate
n=15 participants at risk
2400 mg (3 pills) with each meal sevelamer carbonate : 2400 mg with each meal for 4 weeks
Placebo Control
n=15 participants at risk
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. placebo : 3 tablets with each meal
Gastrointestinal disorders
nausea
6.7%
1/15 • Number of events 1
0.00%
0/15

Additional Information

Kenneth R. Phelps, M.D.

Kenneth R. Phelps, M.D.

Phone: 518-626-5641

Results disclosure agreements

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