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1278863A

Phase 2

Kidney Disease | Small molecule | Nephrology |GSK plc|Last Updated: Nov 11, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

1278863A · 1 trial · 1 indication

Phase 2 1
NCT01047397Repeat Dose Safety and Efficacy Study for Compound to Treat AnemiaKidney Disease
COMPLETED107 Analytics
PHASE2COMPLETED
Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia
Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of response for increase from baseline of hemoglobin levels
Pre-dose, Day 1, Day 15, Day 22, Follow-up
Adverse Events reporting
throughout study
Safety Labs (Chemistry)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Safety Labs (Hematology)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Safety Labs (Urinalysis)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Vital Signs (blood pressure and heart rate)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
ECG
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57

Secondary Endpoints

AUC (0-∞), Cmax, tmax, t½
Day 1, 15, 22
Actual values and change from baseline for erythropoietin, absolute and percent reticulocytes, hematocrit, and total RBCs
Day 1, 15, 22, Folllow-up
Actual values and change from baseline for VEGF, hepcidin, TIBC
Day 1, 15, 22, Follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALActive Drug
Group 2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
1278863ADRUG25mg, 50mg, 100mg
PlaceboDRUGmatching placebo
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: 1. Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent. 2. A male or female is eligible to enroll and participate in this study if he/she: 1. (Part 1) has Moderate to Severe Renal Impairment (equivalent to NKF KDOQI Stage 3 or...

Countries:AustraliaIndiaNew ZealandRussia
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Frequently asked questions about 1278863A

What is 1278863A used for in Kidney Disease?

1278863A is an investigational small molecule being studied for the treatment of Kidney Disease. It is currently in Phase 2 clinical development, with one completed trial that evaluated repeat doses of the compound for anemia in patients with kidney disease.

Who makes 1278863A?

1278863A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational compound for kidney disease.

What phase is 1278863A in?

1278863A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating kidney disease.

What clinical trials is 1278863A in?

1278863A has one completed clinical trial registered as NCT01047397, titled "Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia." This Phase 2 study enrolled 107 participants with kidney disease across Australia, India, New Zealand, and Russia.

Is 1278863A the same as any other drug?

No alternative names for 1278863A have been disclosed. The compound is identified by its developmental code 1278863A and is being investigated by GSK plc for the treatment of kidney disease.