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Lanthanum Carbonate

Phase 3

Kidney Failure, Chronic | Small molecule | Nephrology |Takeda Pharmaceutical Company Limited|Last Updated: Jul 6, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials5
Total Enrollment1,088
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00151918Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal DiseasePHASE3 COMPLETED 48Jan 7, 2005Aug 22, 2005Jul 6, 2021 -
NCT00151931Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving DialysisPHASE3 COMPLETED 456May 11, 2004Jan 12, 2006Jun 8, 2021 -
NCT00150566Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their BloodPHASE3 COMPLETED 460Feb 9, 2004Oct 8, 2005Jun 8, 2021 -
NCT00150540A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.PHASE3 COMPLETED 93Oct 14, 2002Jun 29, 2005Jun 23, 2021 -
NCT00875017Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult VolunteersPHASE1 COMPLETED 31Apr 20, 2009Jun 16, 2009Jun 15, 20211 United States
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Study Endpoints
Primary Endpoints
Mean pre-dialysis serum phosphate level
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Week 3 and Week 5
Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
4 & 8 weeks
Treatment emergent adverse events
Up to 24 months
Net Phosphorous Absorption
10 hours post-dose

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).

Secondary Endpoints
Mean pre-dialysis serum calcium product
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Mean pre-dialysis calcium-phosphate product
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Average daily pill burden
Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Meal + LanthanumEXPERIMENTAL -
Meal + SevelamerACTIVE_COMPARATOR -
Meal OnlyNO_INTERVENTION -
FastingNO_INTERVENTION -
Interventions
NameTypeDescription
Lanthanum carbonateDRUG -
SevelamerDRUG3 x 800mg tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients receiving haemodialysis for ESRD * Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months Exclusion Criteria: * Pregnant or lactating women * Patients with clinically significant uncontrolled concu...

Countries:United States
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