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Maxacalcitol

Phase 2

Chronic Kidney Disease on Hemodialysis | Small molecule | Endocrine |Abbott Laboratories|Last Updated: Jan 20, 2012

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

Maxacalcitol · 1 trial · 2 indications

Phase 2 1
NCT00667576Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving HemodialysisChronic Kidney Disease on Hemodialysis
COMPLETED153 Analytics
PHASE2COMPLETED
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Chronic Kidney Disease on HemodialysisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
Baseline to Week 13 (Final Visit)

Secondary Endpoints

Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
Baseline to Week 13 (Final Visit)
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
Baseline to Week 13 (Final Visit)
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
Through Week 13
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Paricalcitol 2 µg ± 1 µgEXPERIMENTALParicalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg
Paricalcitol 2 µg ± 2 µgEXPERIMENTALParicalcitol initial dosage 2 µg with incremental adjustment of 2 µg
Paricalcitol 4 µg ± 1 µgEXPERIMENTALParicalcitol initial dosage 4 µg with incremental adjustment of 1 µg
Paricalcitol 4 µg ± 2 µgEXPERIMENTALParicalcitol initial dosage 4 µg with incremental adjustment of 2 µg
Maxacalcitol 5 or 10 µg ± 2.5 µgOTHERMaxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg

Interventions

NameTypeDescription
MaxacalcitolDRUGStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.
ParicalcitolDRUGStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period. * Using dialysate with constant concentration of calcium for 4...

Countries:Japan
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Frequently asked questions about Maxacalcitol

What is Maxacalcitol used for?

Maxacalcitol is a small molecule being developed for Chronic Kidney Disease on Hemodialysis. It is being studied for its effects on secondary hyperparathyroidism in patients receiving hemodialysis. The drug is currently in Phase 2 clinical development.

Who makes Maxacalcitol?

Maxacalcitol is being developed by Abbott Laboratories, which trades under the ticker ABT. The company is conducting clinical research on this drug for the treatment of chronic kidney disease patients on hemodialysis.

What phase is Maxacalcitol in?

Maxacalcitol is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its potential use in chronic kidney disease patients on hemodialysis.

What clinical trials is Maxacalcitol in?

Maxacalcitol has one completed clinical trial, NCT00667576, which was a Phase 2 dose-response study of paricalcitol injection in chronic kidney disease patients receiving hemodialysis. The trial enrolled 153 participants in Japan and was controlled but not double-blind.

Is Maxacalcitol the same as paricalcitol?

Maxacalcitol is not the same as paricalcitol. The clinical trial NCT00667576 studied paricalcitol injection, not Maxacalcitol. Maxacalcitol is a separate drug being developed by Abbott Laboratories for chronic kidney disease on hemodialysis.