An interventional study of Lanthanum Carbonate (Fosrenol) and placebo in Metabolic Bone Disease, sponsored by Endeavor Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Endeavor Health · Not applicable, Interventional, and Prevention
The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).
Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.
This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.
261 studies on the registry are indexed under Bone Diseases; 49 are open to participants now.
This study's enrollment of 19 is below the median of 54 across 148 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
Drug: Lanthanum Carbonate (Fosrenol)
Subject will receive placebo
Drug: placebo
Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner
Also known as: Fosrenol
Initial dose of placebo will be 1 pill three times a day
Also known as: sugar pill
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days
Time frame: Baseline, 60 days
Calcium Mean Change From Baseline
Mean change from baseline Calcium level at 60 days
Time frame: Baseline, 60 days
Serum Phosphate Mean Change From Baseline
Mean change from baseline serum phosphate at 60 days
Time frame: Baseline, 60 days
Change From Baseline Serum Parathyroid Hormone
Change from baseline serum parathyroid hormone at 60 days
Time frame: Baseline, 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
Time frame: Baseline, 60 days
25 Hydroxyvitamin D Mean Change From Baseline
Mean change from baseline 25 hydroxyvitamin D at 60 days
Time frame: Baseline, 60 days
Serum Alkaline Phosphatase Mean Change From Baseline
Mean change from baseline serum alkaline phosphatase at 60 days
Time frame: Baseline, 60 days
Serum Osteocalcin Mean Change From Baseline
Mean change from baseline serum osteocalcin at 60 days
Time frame: Baseline, 60 days
24 Hour Urine Phosphate Mean Change From Baseline
Mean change from baseline 24 hour urine phosphate at 60 days
Time frame: Baseline, 60 days
The date of recruitment 10/27/09-3/7/12.The subjects were seen at Evanston and Glenbrook outpatient clinics
| Milestone | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days
| RU/mL | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline | -62.96 ± 55.17 | 9.08 ± 53.84 |
Mean change from baseline Calcium level at 60 days
| mg/dL | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Calcium Mean Change From Baseline | 0.15 ± 0.49 | 0.04 ± 0.72 |
Mean change from baseline serum phosphate at 60 days
| mg/dL | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Serum Phosphate Mean Change From Baseline | 0.18 ± 0.93 | 0.22 ± 0.54 |
Change from baseline serum parathyroid hormone at 60 days
| percent change in PTH | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Change From Baseline Serum Parathyroid Hormone | -18.75 ± 25.91 | -33.25 ± 117.70 |
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
| ng/mL | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline | -1.25 ± 8.66 | -12.20 ± 23.83 |
Mean change from baseline 25 hydroxyvitamin D at 60 days
| ng/mL | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| 25 Hydroxyvitamin D Mean Change From Baseline | 0.43 ± 6.16 | 2.00 ± 7.67 |
Mean change from baseline serum alkaline phosphatase at 60 days
| U/L | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| Serum Alkaline Phosphatase Mean Change From Baseline | -0.50 ± 4.51 | -0.40 ± 1.91 |
Mean change from baseline serum osteocalcin at 60 days
No measurements were reported for this outcome.
Mean change from baseline 24 hour urine phosphate at 60 days
| mg | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| 24 Hour Urine Phosphate Mean Change From Baseline | -148.6 ± 64.3 | 5.2 ± 78.7 |
Collected over 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lanthanum Carbonate (Fosrenol) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Placebo | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Event | Lanthanum Carbonate (Fosrenol) | Placebo |
|---|---|---|
| mildGeneral disorders | 1/10 | 0/9 |
| Age, Categorical(Participants) | Lanthanum Carbonate (Fosrenol) | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 5 | 4 | 9 |
| Sex: Female, Male(Participants) | Lanthanum Carbonate (Fosrenol) | Placebo | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 4 | 10 |
| Region of Enrollment(participants) | Lanthanum Carbonate (Fosrenol) | Placebo | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
Plan to share: Yes — Data will be compiled into a manuscript
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Endeavor Health