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The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal + Lanthanum | Experimental |
| |
| Meal + Sevelamer | Active Comparator |
| |
| Meal Only | No Intervention | ||
| Fasting | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate | Drug | 1 x 1000mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Phosphorous Absorption | Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting). | 10 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Net Phosphorous Binding | Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only. Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only. | 10 hours post-dose |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21354682 | Result | Martin P, Wang P, Robinson A, Poole L, Dragone J, Smyth M, Pratt R. Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study. Am J Kidney Dis. 2011 May;57(5):700-6. doi: 10.1053/j.ajkd.2010.11.028. Epub 2011 Feb 26. | |
| 24197066 | Result |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Patients were randomized to one of 6 treatment sequences each of which consisted of four treatment periods separated by a 7-14 day washout period. In each of the first three treatment periods subjects received lanthanum carbonate 100mg +meal, sevelamer carbonate 2400mg+meal or meal. Subjects fasted in the fourth treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period |
| FG001 | Sequence 2 | Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| FG002 | Sequence 3 | Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| FG003 | Sequence 4 | Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| FG004 | Sequence 5 | Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period |
| FG005 | Sequence 6 | Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout |
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| Second Intervention |
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| Washout |
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| Third Intervention |
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| Washout |
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| Fourth Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period |
| BG001 | Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Although 31 subjects were randomized in the study, the demographics are presented from the Safety Set (n = 28). Safety Set consisted of subjects who had at least one dose of investigational medicinal product and had at least one post-dose safety assessment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Phosphorous Absorption | Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting). | Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set. | Posted | Least Squares Mean | Standard Error | mg | 10 hours post-dose |
|
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Due to the crossover design of the study, discontinuations during the course of the study will affect the number of subjects receiving each treatment. Therefore, the number of subjects for each treatment will be less than 28 (the total number of subjects in the Safety Set).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanthanum Carbonate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sevelamer | Drug | 3 x 800mg tablets |
|
|
| Net Calcium Absorption | Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting). | 10 hours post-dose |
| Behets GJ, Dams G, Damment SJ, Martin P, De Broe ME, D'Haese PC. Differences in gastrointestinal calcium absorption after the ingestion of calcium-free phosphate binders. Am J Physiol Renal Physiol. 2014 Jan 1;306(1):F61-7. doi: 10.1152/ajprenal.00219.2013. Epub 2013 Nov 6. |
| Adverse Event |
|
| Problems collecting rectal effluent |
|
| Intolerance to nasogastric tube |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| BG002 | Sequence 3 | Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| BG003 | Sequence 4 | Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| BG004 | Sequence 5 | Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period |
| BG005 | Sequence 6 | Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period |
| BG006 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Although 31 subjects were randomized in the study, the demographics are presented from the Safety Set (n = 28). Safety Set consisted of subjects who had at least one dose of investigational medicinal product and had at least one post-dose safety assessment. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Although 31 subjects were randomized in the study, the demographics are presented from the Safety Set (n = 28). Safety Set consisted of subjects who had at least one dose of investigational medicinal product and had at least one post-dose safety assessment. | Count of Participants | Participants |
|
| Region of Enrollment | Although 31 subjects were randomized in the study, the demographics are presented from the Safety Set (n = 28). Safety Set consisted of subjects who had at least one dose of investigational medicinal product and had at least one post-dose safety assessment. | Count of Participants | Participants |
|
A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
| OG001 | Sevelamer Carbonate | A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured. |
| OG002 | Meal Only | A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured. |
|
|
|
| Secondary | Net Phosphorous Binding | Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only. Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only. | PD set | Posted | Least Squares Mean | Standard Error | mg | 10 hours post-dose |
|
|
|
|
| Secondary | Net Calcium Absorption | Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting). | PD set | Posted | Least Squares Mean | Standard Error | mg | 10 hours post-dose |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Sevelamer Carbonate | 0 | 24 | 0 | 24 |
| EG002 | Meal Only | 0 | 26 | 3 | 26 |
| EG003 | Fasting | 0 | 20 | 3 | 20 |
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Rash pruritic | Skin and subcutaneous tissue disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.
| Mixed Models Analysis |
| 0.133 |
| LS Mean Difference |
| -15.56 |
| 95 |
| -36.11 |
| 4.99 |
| Superiority or Other (legacy) |
| Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect. | Mixed Models Analysis | 0.612 | LS Mean Difference | 5.11 | 95 | -15.24 | 25.47 | Superiority or Other (legacy) |