Clinical Trial Details
| Trial ID: | L4124 |
| Source ID: | NCT02332824 |
| Associated Drug: | Tak-272 |
| Title: | A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02332824/results |
| Conditions: | Type 2 Diabetes Mellitus and Microalbuminuria |
| Interventions: | DRUG: TAK-272|DRUG: TAK-272 Placebo|DRUG: Candesartan cilexetil|DRUG: Candesartan cilexetil Placebo |
| Outcome Measures: | Primary: Change From End of Pre-treatment Period (Week 0) in Log-transformed Urine Albumin/Creatinine Ratio (UACR) at the End of Treatment Period (Week 12), The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR., Week 0 and Week 12 | Secondary: Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point, The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR. Reported data is geometric mean ratio of UACR at each assessment point relative to Baseline., Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment|Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12), Remission rate is defined as percentage of participants who have UACR \<30 mg/gCr and whose UACR decreased by ≥30% from the value at the end of the pre-treatment period (Week 0)., Week 12|Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12), Progression rate is defined as percentage of participants who have UACR ≥300 mg/gCr and whose UACR increased by ≥30% from the value at the end of the pre-treatment period \[Week 0\]. Meanwhile, the definition of transition to overt nephropathy also includes the case that UACR decreased to \<300 mg/gCr after the transition to overt nephropathy., Week 12 | Other: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug., Up to Week 14 |
| Sponsor/Collaborators: | Sponsor: Takeda |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 415 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-10-16 |
| Completion Date: | 2016-08-18 |
| Results First Posted: | 2018-08-13 |
| Last Update Posted: | 2018-08-13 |
| Locations: | Nagoya-shi, Aichi, Japan|Chiba-shi, Chiba, Japan|Kisarazu-shi, Chiba, Japan|Fukuoka-shi, Fukuoka, Japan|Fukutsu-shi, Fukuoka, Japan|Kitakyuushu-shi, Fukuoka, Japan|Kouriyama-shi, Fukushima, Japan|Anchu-shi, Gunma, Japan|Ota-shi, Gunma, Japan|Ishikari-shi, Hokkaido, Japan|Obihiro-shi, Hokkaido, Japan|Sapporo-shi, Hokkaido, Japan|Kobe-shi, Hyogo, Japan|Nishinomiya-shi, Hyogo, Japan|Moriya-shi, Ibaragi, Japan|Naka-shi, Ibaragi, Japan|Koga, Ibarakgi, Japan|Koga-shi, Ibaraki, Japan|Mito-shi, Ibaraki, Japan|Takamatsu-shi, Kagawa, Japan|Ebina-shi, Kanagawa, Japan|Hiratsuka-shi, Kanagawa, Japan|Kawasaki-shi, Kanagawa, Japan|Miura-shi, Kanagawa, Japan|Shounann-shi, Kanagawa, Japan|Yokohama-shi, Kanagawa, Japan|Kochi-shi, Kochi, Japan|Kumamoto-shi, Kumamoto, Japan|Yatsushiro-shi, Kumamoto, Japan|Kyoto-shi, Kyoto, Japan|Uji-shi, Kyoto, Japan|Sendai-shi, Miyagi, Japan|Miyazaki-shi, Miyazaki, Japan|Azumino-shi, Nagano, Japan|Matsumoto-shi, Nagano, Japan|Nakano-shi, Nagano, Japan|Sasebo-shi, Nagasaki, Japan|Kasaoka-shi, Okayama, Japan|Kurashiki-shi, Okayama, Japan|Naha-shi, Okinawa, Japan|Shimajiri-gun, Okinawa, Japan|Tomigusuku-shi, Okinawa, Japan|Kashiwara-shi, Osaka, Japan|Matsubara-shi, Osaka, Japan|Neyagawa-shi, Osaka, Japan|Osaka-shi, Osaka, Japan|Suita-shi, Osaka, Japan|Tondabayashi-shi, Osaka, Japan|Kawagoe-shi, Saitama, Japan|Kyuki-shi, Saitama, Japan|Saitama-shi, Saitama, Japan|Hamamatsu-shi, Shizuoka, Japan|Shizuoka-shi, Shizuoka, Japan|Koyama-shi, Tochigi, Japan|Shimono-shi, Tochigi, Japan|Chiyoda-ku, Tokyo, Japan|Chuo-ku, Tokyo, Japan|Hachioji-shi, Tokyo, Japan|Hino-shi, Tokyo, Japan|Itabashi-ku, Tokyo, Japan|Katsushika-ku, Tokyo, Japan|Nerima-ku, Tokyo, Japan|Ota-ku, Tokyo, Japan|Shibuya-ku, Tokyo, Japan|Shinagawa-ku, Tokyo, Japan|Shinjuku-ku, Tokyo, Japan|Shinjyuku-ku, Tokyo, Japan|Ube-shi, Yamaguchi, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02332824 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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