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DKD Phase 2 Gilead

This study aims to evaluate the efficacy, safety, and tolerability of GS-4997 in treating diabetic kidney disease. Over the course of 48 weeks, 300 subjects with DKD will be randomized to receive either a placebo or GS-4997 at doses of 2 mg, 6 mg, or 18 mg daily. The primary endpoint is the change in estimated glomerular filtration rate from baseline to week 48. Secondary endpoints include the percentage of subjects achieving a 30% reduction in proteinuria and changes in fasting blood glucose, HbA1c, and weight. Subjects will be recruited across 100 sites in the US and will complete regular study visits and assessments over 56 weeks.

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Wynn Htun
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Download as PPTX, PDF, TXT or read online on Scribd
22 views

DKD Phase 2 Gilead

This study aims to evaluate the efficacy, safety, and tolerability of GS-4997 in treating diabetic kidney disease. Over the course of 48 weeks, 300 subjects with DKD will be randomized to receive either a placebo or GS-4997 at doses of 2 mg, 6 mg, or 18 mg daily. The primary endpoint is the change in estimated glomerular filtration rate from baseline to week 48. Secondary endpoints include the percentage of subjects achieving a 30% reduction in proteinuria and changes in fasting blood glucose, HbA1c, and weight. Subjects will be recruited across 100 sites in the US and will complete regular study visits and assessments over 56 weeks.

Uploaded by

Wynn Htun
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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DKD Phase 2

GILEAD
Topics

• Study Description
• Study Overview
• Recruitment Overview
• Study Drug Overview
• Assessment Overview
Study Description

• Protocol #GS-US-223-1015
• “A Phase 2 Double-Blind, Placebo-Controlled, Dose-Ranging
Study Evaluating the Efficacy, Safety and Tolerability of GS
4997 in Subjects with Diabetic Kidney Disease”
Study Overview

• Primary Endpoint:
• Change in eGFR from baseline to Week 48

• Secondary Endpoint:
• Percentage of subjects achieving >30% reduction in proteinuria from
baseline to Week 48
Study Overview

• Exploratory Endpoints:
• change in
• FBG
• OGTT
• Weight from baseline through the treatment
period

• proportion of subjects with HbA1C>7%


Study Overview

• Inclusion criteria
• documented diagnosis of DKD
• T2DM diagnosis for at least 6 months
• Age 30-75
• Mean eGFR >15 and <50
• Stable dose of ACEI or ARB at a minimum dose for at least 3 months
• SBP 110-160 , DBP 50-90
• Negative serum pregnancy test for female subjects
• negative for HIV, HBV and HCV
Study Overview

• Exclusion Criteria
• T1DM or non DKD
• HbA1C > 9.5%
• ESRD
• Sickle cell disease or trait
• Unstable CVD - Angina, MI, Stroke or TIA, HCMP, CHF IIIb or IV
• Procedures requiring IV contrast
• immunosuppressive drugs
• Concurrent participant in another clinical trial
Study Schema

1-4 Weeks
• screening and randomization
48 Weeks
• Treatment with placebo or GS-4997 2, 6 and 18mg oral once daily
• Visits Week 1, 2, 3 , 4, 8, 12, 16, 24, 36, 47, 48, 52 = 12 visits
4 Weeks
• End of treatment and end of study
Recruitment Overview

• 100 sites in US
• 600 subjects screened
• 300 subjects randomized
• Recruitment and enrollment period 1 year
• Participation time 56 weeks
Study Drug Overview

• Round, plain-faced, white film-coated tablets:


• placebo
• 2 mg tablet
• 6 mg tablet
• 18 mg tablet

• identical in size, shape and appearance

• bottles containing 30 tablets

• Expire March 2016


Study Drug Overview

• self administered
• once daily
• orally
• with water
• each morning
• with or without food
Assessment Overview

• At Screening
• H & P (complete with waist circumference)
• Pregnancy test
• HIV, HBV and HCV serology
• Every Visit
• PE (limited)
• Vitals
• EKG
• CBC, RC, CMP, Mg, Phos
• UACR
Assessment Overview

• OGTT
• Day 1, week 12 and 48
• HbA1C
• Day 1, week 12, 24 and 48
• FBG and Insulin level
• Day 1, week 4, 12, 24, 48
• Urine pregnancy test
• Day 1, week 4, 8, 12, 16, 24, 36 and 48
• Drug dispensing
• Day 1, Week 4, 8, 12, 16, 24 and 36
First research area
Group member name
Supporting content

Heading Heading
• List item • List item
• List item • List item
• List item • List item
Supporting content

T
I TI TI TI TI
e
t et et et et
x
e xe xe xe xe
tm tm tm tm tm
Data observations

5
5
4.4 4.5
4.3
4
3.5
Axis Title

3
3 2.8
2.4 2.5
2 2
2 1.8

0
Category 1 Category 2 Category 3 Category 4

Series 1 Series 2 Series 3


Second Research Area
Group member name
Supporting content

Heading Heading
• List item • List item
• List item • List item
• List item • List item
Supporting content

Item Item
Optional statement Item

Item Item
Supporting content

Heading Heading Heading Heading

Text Text Text Text

Text Text Text Text

Text Text Text Text

Text Text Text Text


Third research area
Group member name
Supporting content

Heading Heading
• List item • List item
• List item • List item
• List item • List item
Data observations

4
Axis Title

First
3 Second
Third
2

0
Test 1 Test 2 Test 3 Test 4
Data
Observations

9%

10%

Item 1
Item 2
Optional statement Item 3
Item 4
23% 59%
Project Summary
Optional statement
Conclusion

• Brief summary of what you discovered based on research


Appendix

• Works cited
• Additional supporting data

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