A Phase 3 interventional study of Fosrenol (Lanthanum Carbonate) and Sevelamer hydrochloride in Chronic Kidney Disease, Stage 5, sponsored by Shire. Completed at 44 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Shire · Phase 3, Interventional, and Treatment
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 182 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fosrenol (Lanthanum carbonate)
Drug: Fosrenol (Lanthanum Carbonate)
Sevelamer hydrochloride
Drug: Sevelamer hydrochloride
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Also known as: FOSRENOL
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time frame: 4 weeks
Change From Baseline in Serum Calcium Levels at 4 Weeks
Time frame: 4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Time frame: Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
Time frame: 4 weeks
Following Washout 1, eligible subjects with serum phosphorus levels greater than or equal to 6.0mg/dL (greater than or equal to 1.94mmol/L) and calcium levels greater than or equal to 8.4mg/dL (greater than or equal to 2.10mmol/L) were randomized in a 1:1 ratio to receive either Fosrenol or sevelamer hydrochloride (HCl) for 4 weeks.
| Milestone | Fosrenol First | Sevelamer HCl First |
|---|---|---|
| Started | 95 | 87 |
| Completed | 77 | 75 |
| Not completed | 18 | 12 |
| Withdrew: Adverse event | 6 | 5 |
| Withdrew: Protocol violation | 2 | 2 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Kidney transplant | 1 | 1 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Subject exceeded safety criteria | 0 | 1 |
| Withdrew: Subject met an exclusionary criteria | 1 | 0 |
| Withdrew: Extended hospitalization | 1 | 0 |
| Withdrew: Site error | 1 | 0 |
| Withdrew: Sponsor's request | 1 | 0 |
| Milestone | Fosrenol First | Sevelamer HCl First |
|---|---|---|
| Started | 77 | 75 |
| Completed | 77 | 75 |
| Not completed | 0 | 0 |
| Milestone | Fosrenol First | Sevelamer HCl First |
|---|---|---|
| Started | 77 | 75 |
| Completed | 65 | 68 |
| Not completed | 12 | 7 |
| Withdrew: Adverse event | 5 | 2 |
| Withdrew: Protocol violation | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Kidney transplant | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Subject exceeded safety criteria | 1 | 0 |
| Withdrew: Subject moved | 0 | 1 |
| mg/dL | Fosrenol | Sevelamer HCl |
|---|---|---|
| Change From Baseline in Serum Phosphorus Levels at 4 Weeks | -1.73 ± 0.129 | -1.44 ± 0.132 |
| mg/dL | Fosrenol | Sevelamer HCl |
|---|---|---|
| Change From Baseline in Serum Calcium Levels at 4 Weeks | 0.06 ± 0.045 | -0.06 ± 0.046 |
| pg/mL | Fosrenol | Sevelamer HCl |
|---|---|---|
| Baseline | 225.46 ± 11.094 | 225.46 ± 11.094 |
| Endpoint | 296.48 ± 17.412 | 291.18 ± 16.181 |
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
| Percentage of Participants | Fosrenol | Sevelamer HCl |
|---|---|---|
| Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks | 42.7 | 34.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fosrenol | — | 18/170 (10.6%) | 31/170 (18.2%) |
| Sevelamer HCl | — | 20/163 (12.3%) | 27/163 (16.6%) |
| Event | Fosrenol | Sevelamer HCl |
|---|---|---|
| Extremity necrosisSkin and subcutaneous tissue disorders | 0/170 | 3/163 |
| PneumoniaInfections and infestations | 3/170 | 1/163 |
| Cerebral vascular accidentNervous system disorders | 3/170 | 0/163 |
| Congestive heart failureCardiac disorders | 1/170 | 2/163 |
| Clostridium difficile colitisInfections and infestations | 0/170 | 2/163 |
| Myocardial infarctionCardiac disorders | 2/170 | 2/163 |
| WeaknessGeneral disorders | 0/170 | 2/163 |
| Coronary atery diseaseCardiac disorders | 2/170 | 2/163 |
| OsteomyelitisInfections and infestations | 2/170 | 1/163 |
| Chest painGeneral disorders | 2/170 | 0/163 |
| Event | Fosrenol | Sevelamer HCl |
|---|---|---|
| NauseaGastrointestinal disorders | 15/170 | 9/163 |
| DiarrheaGastrointestinal disorders | 12/170 | 12/163 |
| VomitingGastrointestinal disorders | 9/170 | 6/163 |
| Age, Categorical(Participants) | Entire Study Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 140 |
| >=65 years | 42 |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 55.5 ± 13.10 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 80 |
| Male | 102 |
| Region of Enrollment(Participants) | Entire Study Population |
|---|---|
| United States | 139 |
| Puerto Rico | 1 |
| Germany | 41 |
| United Kingdom | 1 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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