Trial Outcomes & Findings for Healthy Combine Study (NCT NCT03136705)
NCT ID: NCT03136705
Last Updated: 2024-02-23
Results Overview
Longitudinal change in serum intact FGF23 levels from baseline visit through completion of study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Approximately 3 weeks.
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Lanthanum + Nicotinamide
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Combine Study
Baseline characteristics by cohort
| Measure |
Lanthanum + Nicotinamide
n=9 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
n=10 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
n=10 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
n=10 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 15.1 • n=93 Participants
|
27.1 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
29.4 years
STANDARD_DEVIATION 13.4 • n=27 Participants
|
26.6 years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
30.0 years
STANDARD_DEVIATION 13 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
BMI
|
25.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=93 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 2.7 • n=4 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 3.9 • n=27 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=483 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 3.7 • n=36 Participants
|
|
Systolic blood pressure
|
109.3 mmHg
STANDARD_DEVIATION 10.6 • n=93 Participants
|
111.5 mmHg
STANDARD_DEVIATION 12.3 • n=4 Participants
|
115.8 mmHg
STANDARD_DEVIATION 6.9 • n=27 Participants
|
108.2 mmHg
STANDARD_DEVIATION 11.6 • n=483 Participants
|
111.3 mmHg
STANDARD_DEVIATION 10.6 • n=36 Participants
|
|
Serum Phosphate
|
3.4 mg/dL
STANDARD_DEVIATION 0.5 • n=93 Participants
|
3.6 mg/dL
STANDARD_DEVIATION 0.4 • n=4 Participants
|
3.4 mg/dL
STANDARD_DEVIATION 0.3 • n=27 Participants
|
3.6 mg/dL
STANDARD_DEVIATION 0.5 • n=483 Participants
|
3.5 mg/dL
STANDARD_DEVIATION 0.4 • n=36 Participants
|
|
Serum Creatinine
|
0.8 mg/dL
STANDARD_DEVIATION 0.2 • n=93 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.2 • n=4 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.2 • n=27 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.1 • n=483 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.2 • n=36 Participants
|
|
Urine 24 hour Phosphate total
|
511.8 mg
STANDARD_DEVIATION 210.7 • n=93 Participants
|
678.0 mg
STANDARD_DEVIATION 218.8 • n=4 Participants
|
799.0 mg
STANDARD_DEVIATION 265.1 • n=27 Participants
|
679.7 mg
STANDARD_DEVIATION 244.5 • n=483 Participants
|
671.1 mg
STANDARD_DEVIATION 248.7 • n=36 Participants
|
|
Urine 24 hour Creatinine total
|
1114.3 mg
STANDARD_DEVIATION 411.2 • n=93 Participants
|
1505.5 mg
STANDARD_DEVIATION 588.0 • n=4 Participants
|
1646.7 mg
STANDARD_DEVIATION 536.5 • n=27 Participants
|
1489.8 mg
STANDARD_DEVIATION 478.8 • n=483 Participants
|
1447.4 mg
STANDARD_DEVIATION 527.3 • n=36 Participants
|
|
Urine 24 hour Calcium total
|
59.6 mg
n=93 Participants
|
129.9 mg
n=4 Participants
|
175.2 mg
n=27 Participants
|
102.0 mg
n=483 Participants
|
118.5 mg
n=36 Participants
|
|
Urine 8 hour Phosphate total
|
280.9 mg
STANDARD_DEVIATION 135.0 • n=93 Participants
|
377.5 mg
STANDARD_DEVIATION 160.8 • n=4 Participants
|
407.3 mg
STANDARD_DEVIATION 184.8 • n=27 Participants
|
327.6 mg
STANDARD_DEVIATION 102.6 • n=483 Participants
|
350.4 mg
STANDARD_DEVIATION 149.8 • n=36 Participants
|
|
Urine 8 hour Creatinine total
|
478.5 mg
STANDARD_DEVIATION 218.1 • n=93 Participants
|
646.9 mg
STANDARD_DEVIATION 224.3 • n=4 Participants
|
687.1 mg
STANDARD_DEVIATION 225.3 • n=27 Participants
|
532.2 mg
STANDARD_DEVIATION 116.3 • n=483 Participants
|
591.8 mg
STANDARD_DEVIATION 209.5 • n=36 Participants
|
|
Urine 8 hour Calcium total
|
50.1 mg
n=93 Participants
|
60.2 mg
n=4 Participants
|
66.4 mg
n=27 Participants
|
57.3 mg
n=483 Participants
|
59.4 mg
n=36 Participants
|
|
Intact FGF23
|
68.0 pg/ml
n=93 Participants
|
66.9 pg/ml
n=4 Participants
|
54.2 pg/ml
n=27 Participants
|
72.3 pg/ml
n=483 Participants
|
66.2 pg/ml
n=36 Participants
|
|
C-terminal FG23
|
66.3 RU/ml
n=93 Participants
|
82.1 RU/ml
n=4 Participants
|
80.7 RU/ml
n=27 Participants
|
90.7 RU/ml
n=483 Participants
|
79.0 RU/ml
n=36 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 weeks.Population: intention to treat
Longitudinal change in serum intact FGF23 levels from baseline visit through completion of study.
Outcome measures
| Measure |
Lanthanum + Nicotinamide
n=9 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
n=10 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
n=10 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
n=9 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
|---|---|---|---|---|
|
Change in Intact FGF23
|
1.001 pg/ml
Interval 0.978 to 1.024
|
1.006 pg/ml
Interval 0.983 to 1.029
|
1.009 pg/ml
Interval 0.987 to 1.032
|
1.005 pg/ml
Interval 0.995 to 1.014
|
SECONDARY outcome
Timeframe: Approximately 3 weeks.Population: intention to treat
Longitudinal change in plasma phosphorus levels from baseline visit through completion of study.
Outcome measures
| Measure |
Lanthanum + Nicotinamide
n=9 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
n=10 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
n=10 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
n=9 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
|---|---|---|---|---|
|
Change in Plasma Phosphorus Level
|
0.0099 mg/dl
Interval -0.0407 to 0.0604
|
-0.0102 mg/dl
Interval -0.0596 to 0.0392
|
0.0099 mg/dl
Interval -0.0395 to 0.0593
|
0.0004 mg/dl
Interval -0.0202 to 0.021
|
SECONDARY outcome
Timeframe: Approximately 3 weeks.Population: intention to treat
Longitudinal change in 24 hour urinary phosphorus levels from baseline visit through completion of study.
Outcome measures
| Measure |
Lanthanum + Nicotinamide
n=9 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
n=10 Participants
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
n=10 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
n=9 Participants
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
|---|---|---|---|---|
|
Change in 24 Hour Urinary Phosphorus Level
|
-10.24 mg
Interval -33.94 to 13.47
|
-5.88 mg
Interval -29.13 to 17.37
|
1.29 mg
Interval -22.11 to 24.69
|
-10.85 mg
Interval -20.56 to -1.13
|
Adverse Events
Lanthanum + Nicotinamide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lanthanum + Nicotinamide Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lanthanum Placebo + Nicotinamide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lanthanum Placebo + Nicotinamide 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
| Measure |
Lanthanum + Nicotinamide
n=9 participants at risk
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate: Lanthanum Carbonate tablet
|
Lanthanum + Nicotinamide Placebo
n=10 participants at risk
Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate: Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
Lanthanum Placebo + Nicotinamide
n=10 participants at risk
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks
Nicotinamide: Nicotinamide tablet
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
|
Lanthanum Placebo + Nicotinamide Placebo
n=9 participants at risk
Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks
Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet
Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/9 • Duration of the study, which with study visit windows was approximately 3 weeks
Adverse event reporting did not differ from what is described under clinicaltrials.gov.
|
10.0%
1/10 • Number of events 1 • Duration of the study, which with study visit windows was approximately 3 weeks
Adverse event reporting did not differ from what is described under clinicaltrials.gov.
|
0.00%
0/10 • Duration of the study, which with study visit windows was approximately 3 weeks
Adverse event reporting did not differ from what is described under clinicaltrials.gov.
|
0.00%
0/9 • Duration of the study, which with study visit windows was approximately 3 weeks
Adverse event reporting did not differ from what is described under clinicaltrials.gov.
|
Additional Information
Doctor
Northwestern University Feinberg School of Medicine
Phone: 312-503-6921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place