A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

Conditions

• Diabetic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.

Key Dates

Start date

Aug 31, 2012

Status verified

Sep 2019

Primary completion

Sep 30, 2014

Completion

Nov 30, 2014

Study Design

Enrollment

130 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.
• Experimental: Baricitinib 0.75 mg/0.5 mg QD
  Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
• Experimental: Baricitinib 0.75 mg/0.5 mg BID
  Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
• Experimental: Baricitinib 1.5 mg/1 mg
  Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
• Experimental: Baricitinib 4 mg/2.75 mg
  Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Primary Outcome Measure

Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (35)

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