NCT02410499

Efficacy and Safety of Weekly Subcutaneous MLN1202 in Improving Diabetic Nephropathy in Participants With Macroalbuminuria

A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy in Subjects With Macroalbuminuria

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR\>300 mg/g) based on average of 3 consecutive first morning voids sample collection.

Detailed description

The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have diabetes with macroalbuminuria. This study will look at the urinary albumin-to-creatinine ratio in people who take MLN1202. The study will enroll approximately 156 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * MLN1202 75 mg subcutaneous (SC) injection * MLN1202 105 mg SC injection * MLN1202 150 mg SC injection * Placebo matching MLN1202 SC injection (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient All participants will receive a loading dose of placebo or MLN1202 on Day 1 followed by once-weekly injections of the study medication they were randomized to receive. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 months. Participants will make multiple visits to the clinic, plus a final visit 5 weeks after the last dose of study drug for a follow-up assessment.

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	MLN1202 Placebo	MLN1202 placebo-matching solution for SC injection
DRUG	MLN1202	MLN1202 solution for SC injection

Timeline

• Start date: 2015-05-20
• Primary completion: 2015-11-17
• Completion: 2015-11-17
• First posted: 2015-04-07
• Last updated: 2017-09-25