Trial Outcomes & Findings for The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE (NCT NCT02258074)
NCT ID: NCT02258074
Last Updated: 2021-08-02
Results Overview
Change from baseline to 12 months in FGF23 level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2021-08-02
Participant Flow
Participant milestones
| Measure |
Lanthanum Carbonate + Nicotinamide
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
51
|
51
|
|
Overall Study
COMPLETED
|
52
|
50
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lanthanum Carbonate + Nicotinamide
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Baseline characteristics by cohort
| Measure |
Lanthanum Carbonate + Nicotinamide
n=53 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
n=50 Participants
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
n=51 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
n=51 Participants
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 12 • n=5 Participants
|
67 years
STANDARD_DEVIATION 13 • n=7 Participants
|
70 years
STANDARD_DEVIATION 12 • n=5 Participants
|
69 years
STANDARD_DEVIATION 10 • n=4 Participants
|
69 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
50 participants
n=7 Participants
|
51 participants
n=5 Participants
|
51 participants
n=4 Participants
|
205 participants
n=21 Participants
|
|
Diabetes Mellitus
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Systolic BP
|
126.0 mm Hg
STANDARD_DEVIATION 15.0 • n=5 Participants
|
129.2 mm Hg
STANDARD_DEVIATION 17.2 • n=7 Participants
|
129.7 mm Hg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
129.3 mm Hg
STANDARD_DEVIATION 21.2 • n=4 Participants
|
128.5 mm Hg
STANDARD_DEVIATION 17.3 • n=21 Participants
|
|
Diastolic BP
|
70.2 mm Hg
STANDARD_DEVIATION 11.1 • n=5 Participants
|
71.1 mm Hg
STANDARD_DEVIATION 11.7 • n=7 Participants
|
72.0 mm Hg
STANDARD_DEVIATION 12.5 • n=5 Participants
|
71.5 mm Hg
STANDARD_DEVIATION 12.8 • n=4 Participants
|
71.2 mm Hg
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Body Mass Index
|
33.2 kg / m^2
STANDARD_DEVIATION 8.5 • n=5 Participants
|
30.9 kg / m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
32.5 kg / m^2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
31.0 kg / m^2
STANDARD_DEVIATION 6.1 • n=4 Participants
|
31.9 kg / m^2
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
eGFR
|
32.2 (ml/min/1.73m^2)
STANDARD_DEVIATION 7.2 • n=5 Participants
|
33.0 (ml/min/1.73m^2)
STANDARD_DEVIATION 7.9 • n=7 Participants
|
32.1 (ml/min/1.73m^2)
STANDARD_DEVIATION 7.1 • n=5 Participants
|
32.3 (ml/min/1.73m^2)
STANDARD_DEVIATION 7.0 • n=4 Participants
|
32.4 (ml/min/1.73m^2)
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
Urine Albumin Creatinine Ratio
|
0.1 (g/g) (range is 10th and 90th pctl)
n=5 Participants
|
0.2 (g/g) (range is 10th and 90th pctl)
n=7 Participants
|
0.1 (g/g) (range is 10th and 90th pctl)
n=5 Participants
|
0.2 (g/g) (range is 10th and 90th pctl)
n=4 Participants
|
0.1 (g/g) (range is 10th and 90th pctl)
n=21 Participants
|
|
Calcitriol Use
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Serum Phosphate
|
3.6 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.7 mg/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
3.8 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.6 mg/dL
STANDARD_DEVIATION 0.5 • n=4 Participants
|
3.7 mg/dL
STANDARD_DEVIATION 0.6 • n=21 Participants
|
|
Serum FGF-23
|
104.0 pg/ml (range is 10th to 90th pctls)
n=5 Participants
|
94.8 pg/ml (range is 10th to 90th pctls)
n=7 Participants
|
103.5 pg/ml (range is 10th to 90th pctls)
n=5 Participants
|
96.4 pg/ml (range is 10th to 90th pctls)
n=4 Participants
|
98.8 pg/ml (range is 10th to 90th pctls)
n=21 Participants
|
|
Serum Calcium
|
9.5 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
9.5 mg/dL
STANDARD_DEVIATION 0.5 • n=7 Participants
|
9.5 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
9.5 mg/dL
STANDARD_DEVIATION 0.5 • n=4 Participants
|
9.5 mg/dL
STANDARD_DEVIATION 0.5 • n=21 Participants
|
|
Intact PTH
|
121.4 pg/ml
STANDARD_DEVIATION 88.7 • n=5 Participants
|
123.2 pg/ml
STANDARD_DEVIATION 75.8 • n=7 Participants
|
115.6 pg/ml
STANDARD_DEVIATION 80.4 • n=5 Participants
|
124.6 pg/ml
STANDARD_DEVIATION 94.7 • n=4 Participants
|
121.2 pg/ml
STANDARD_DEVIATION 84.8 • n=21 Participants
|
|
Urine Phosphorus
|
657.4 mg/24 hrs
STANDARD_DEVIATION 265.2 • n=5 Participants
|
658.5 mg/24 hrs
STANDARD_DEVIATION 267.9 • n=7 Participants
|
712.8 mg/24 hrs
STANDARD_DEVIATION 235.0 • n=5 Participants
|
644.4 mg/24 hrs
STANDARD_DEVIATION 245.2 • n=4 Participants
|
668.1 mg/24 hrs
STANDARD_DEVIATION 252.9 • n=21 Participants
|
|
Phosphorus/Creatinine Ratio
|
447.0 mg/g
STANDARD_DEVIATION 146.1 • n=5 Participants
|
451.6 mg/g
STANDARD_DEVIATION 120.9 • n=7 Participants
|
487.4 mg/g
STANDARD_DEVIATION 126.4 • n=5 Participants
|
462.9 mg/g
STANDARD_DEVIATION 130.7 • n=4 Participants
|
462.1 mg/g
STANDARD_DEVIATION 131.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Adults with CKD
Change from baseline to 12 months in FGF23 level.
Outcome measures
| Measure |
Lanthanum Carbonate + Nicotinamide
n=53 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
n=50 Participants
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
n=51 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
n=51 Participants
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
FGF23
|
.047 pg/ml
Interval -0.056 to 0.151
|
-.003 pg/ml
Interval -0.109 to 0.104
|
.193 pg/ml
Interval 0.085 to 0.303
|
.138 pg/ml
Interval 0.033 to 0.233
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsChange from Baseline to 12 months in serum phosphate level
Outcome measures
| Measure |
Lanthanum Carbonate + Nicotinamide
n=53 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
n=50 Participants
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
n=51 Participants
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
n=51 Participants
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
Serum Phosphate (mg/dl)
|
0.06 mg/dl
Interval -0.08 to 0.2
|
0.06 mg/dl
Interval -0.09 to 0.21
|
0.12 mg/dl
Interval -0.03 to 0.27
|
0.12 mg/dl
Interval -0.01 to 0.26
|
Adverse Events
Lanthanum Carbonate + Nicotinamide
Serious events: 18 serious events
Other events: 33 other events
Deaths: 1 deaths
Lanthanum Carbonate + Nicotinamide Placebo
Serious events: 14 serious events
Other events: 29 other events
Deaths: 0 deaths
Lanthanum Carbonate Placebo and Nicotinamide
Serious events: 14 serious events
Other events: 30 other events
Deaths: 1 deaths
Lanthanum Carbonate Placebo and Nicotinamide Placebo
Serious events: 14 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lanthanum Carbonate + Nicotinamide
n=53 participants at risk
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
n=50 participants at risk
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
n=51 participants at risk
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
n=51 participants at risk
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiovascular Hospitalizations
|
15.1%
8/53 • Number of events 12 • 1 year
|
8.0%
4/50 • Number of events 5 • 1 year
|
7.8%
4/51 • Number of events 6 • 1 year
|
11.8%
6/51 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
GI Hospitalizations
|
3.8%
2/53 • Number of events 2 • 1 year
|
10.0%
5/50 • Number of events 5 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Hepatobiliary disorders
Hepatic Hospitalizations
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
Reached ESRD (dialysis or transplant)
|
7.5%
4/53 • Number of events 4 • 1 year
|
2.0%
1/50 • Number of events 1 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection-related Hospitalizations
|
5.7%
3/53 • Number of events 3 • 1 year
|
6.0%
3/50 • Number of events 3 • 1 year
|
5.9%
3/51 • Number of events 3 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal Hospitalizations
|
9.4%
5/53 • Number of events 5 • 1 year
|
4.0%
2/50 • Number of events 2 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
5.9%
3/51 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy
|
3.8%
2/53 • Number of events 2 • 1 year
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
0.00%
0/53 • 1 year
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Nervous system disorders
Nervous System
|
3.8%
2/53 • Number of events 2 • 1 year
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/53 • 1 year
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
5.7%
3/53 • Number of events 3 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.9%
1/53 • Number of events 1 • 1 year
|
2.0%
1/50 • Number of events 1 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Endocrine disorders
Endocrine
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 2 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Lanthanum Carbonate + Nicotinamide
n=53 participants at risk
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Lanthanum Carbonate
|
Lanthanum Carbonate + Nicotinamide Placebo
n=50 participants at risk
Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.
Lanthanum Carbonate
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide
n=51 participants at risk
One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Nicotinamide
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
Lanthanum Carbonate Placebo and Nicotinamide Placebo
n=51 participants at risk
One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.
Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea (severe)
|
20.8%
11/53 • Number of events 20 • 1 year
|
18.0%
9/50 • Number of events 15 • 1 year
|
7.8%
4/51 • Number of events 9 • 1 year
|
7.8%
4/51 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Heartburn (severe)
|
3.8%
2/53 • Number of events 3 • 1 year
|
6.0%
3/50 • Number of events 5 • 1 year
|
0.00%
0/51 • 1 year
|
7.8%
4/51 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Diarrhea (severe)
|
22.6%
12/53 • Number of events 22 • 1 year
|
10.0%
5/50 • Number of events 8 • 1 year
|
15.7%
8/51 • Number of events 14 • 1 year
|
13.7%
7/51 • Number of events 15 • 1 year
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.9%
1/53 • Number of events 1 • 1 year
|
10.0%
5/50 • Number of events 14 • 1 year
|
7.8%
4/51 • Number of events 7 • 1 year
|
7.8%
4/51 • Number of events 8 • 1 year
|
|
Immune system disorders
Hives
|
1.9%
1/53 • Number of events 3 • 1 year
|
10.0%
5/50 • Number of events 5 • 1 year
|
17.6%
9/51 • Number of events 13 • 1 year
|
0.00%
0/51 • 1 year
|
|
Blood and lymphatic system disorders
Bruising
|
37.7%
20/53 • Number of events 57 • 1 year
|
32.0%
16/50 • Number of events 32 • 1 year
|
41.2%
21/51 • Number of events 55 • 1 year
|
35.3%
18/51 • Number of events 47 • 1 year
|
|
Blood and lymphatic system disorders
Bleeding
|
18.9%
10/53 • Number of events 18 • 1 year
|
26.0%
13/50 • Number of events 21 • 1 year
|
19.6%
10/51 • Number of events 22 • 1 year
|
13.7%
7/51 • Number of events 14 • 1 year
|
|
Renal and urinary disorders
Serum Phosphate >= 5.9 mg/dl
|
1.9%
1/53 • Number of events 2 • 1 year
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
Serum Phosphate < 1.5 mg/dl
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Blood and lymphatic system disorders
Platelets < 100,000
|
1.9%
1/53 • Number of events 2 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
3.9%
2/51 • Number of events 4 • 1 year
|
|
Hepatobiliary disorders
Liver Function Abnormalities
|
0.00%
0/53 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
Creatine Kinase > 800 U/L
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/50 • 1 year
|
0.00%
0/51 • 1 year
|
0.00%
0/51 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place