Clinical Trials List
Protocol NumberM11-350
2011-09-01 - 2012-07-31
Phase II
Terminated3
ICD-10R80.0
Isolated proteinuria
ICD-10R80.1
Persistent proteinuria, unspecified
ICD-10R80.3
Bence Jones proteinuria
ICD-10R80.8
Other proteinuria
ICD-10R80.9
Proteinuria, unspecified
ICD-9791.0
Proteinuria
RADAR: Reducing Residual Albuminuria in Subjects with Diabetes and Nephropathy with Atrasentan- A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and Efficacy
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Trial Applicant
AbbVie
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Sponsor
Abbvie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 王子源 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李亦德 Division of Endocrinology
- 李文珍 Division of Endocrinology
- 傅家保 Division of Endocrinology
- JUN-SING WANG Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Kun Der Lin Division of Endocrinology
- Shyi-Jang Shin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Reduce residual albuminuria in patients with diabetes and kidney disease
Objectives
The purpose of this study was to evaluate the reduction in Atrasentan tablets (0.75 mg and 1.25 mg) taken once a day in patients with type 2 diabetes and nephropathy who were treated with the maximum tolerable label dose of RAS inhibitors compared with taking placebo. Efficacy and safety of residual proteinuria
Test Drug
ABT-627
Active Ingredient
Dosage Form
Dosage
0.5/0.75
Endpoints
The change in UACR (urinary albumin to creatinine acid ratio) from the baseline date to the 12th week will be performed by repeated measurement analysis using all the data collected at the baseline date and every visit after the baseline date. analysis. The UACR level will be determined using the median value of the first morning urine for each subject at the baseline date and each visit after the baseline date.
Pharmacokinetics: The population pharmacokinetic technique can be used to estimate the oral clearance (CL/F) and volume of distribution (V/F) of Atrasentan.
Pharmacodynamics: Group exposure and response techniques can be used to explore the relationship between Atrasentan exposure and clinical efficacy or safety response.
Pharmacokinetics: The population pharmacokinetic technique can be used to estimate the oral clearance (CL/F) and volume of distribution (V/F) of Atrasentan.
Pharmacodynamics: Group exposure and response techniques can be used to explore the relationship between Atrasentan exposure and clinical efficacy or safety response.
Inclution Criteria
1. The patient must have type 2 diabetes and have been treated with anti-hyperglycemic drugs at least once within 12 months before the screening period.
2. The patient is currently receiving ACEi or ARB (RAS inhibitor).
3. If the patient is a female, she is not currently breastfeeding and she is not pregnant (verified by a negative serum pregnancy test before the treatment period). patient
No fertility potential, defined as at least one year after menopause or having undergone ligation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
Except), or have reproductive potential but use one of the following contraceptive methods:
-Double barrier method of contraception (any two of the following methods: condom, contraceptive cotton, contraceptive diaphragm with spermicidal cream)
-Use hormonal contraceptives (oral, intravenous or transdermal absorption) at least 3 months before and during the study drug
Or intrauterine contraceptive device [IUD], and use a barrier method (condom, contraceptive cotton, contraceptive diaphragm, contraceptive with spermicide
ring).
-Use a barrier method with a partner who has removed the vas deferens (condom, contraceptive cotton, contraceptive diaphragm with spermicidal cream)
-Total prohibition of sexual intercourse during the study period (abstinence for at least one full menstrual cycle before the study began)
Contraception must be used during the entire study period and for at least 4 weeks after receiving the last dose of study drug.
4. Before entering the dose adjustment period, the patient's screening laboratory laboratory test values must meet the following requirements:
-According to the CKD Epidemiological Cooperation (EPI) formula, the estimated value is ≧30 and ≦75 mL/min/1.73m2
-UACR ≧300 and ≦3500 mg/g determined by the geometric mean of the first urine samples obtained from the screening visits in the two mornings
-Serum albumin concentration ≧3.0 g/dL
-BNP≦200 pg/mL
-The female patient's serum pregnancy test result was negative
-SBP≧110 mmHg and≦180 mmHg
-HbA1c≦12%
5. Before entering the treatment period, according to the laboratory test values of the last visit during the dose adjustment period, the patient must meet the following requirements:
-The RAS inhibitor is the maximum tolerated label dose in the past 4 weeks, without dose adjustment
-Any dose of diuretic, unless there is a medical contraindication (cyclic diuretic furosemide QD≧120 mg, or bumetanide QD≧
3.3 mg, or etaneric acid QD ≧ 150 mg, or torasemide QD ≧ 60 mg)
-UACR ≧200 and ≦3500 mg/g determined by the median value of the first urine samples obtained in the first three mornings before the first week of consultation
-SBP≧110 mmHg and≦160 mmHg
-Serum potassium concentration≦5.5 mEq/L
-The female patient's serum pregnancy test result was negative.
2. The patient is currently receiving ACEi or ARB (RAS inhibitor).
3. If the patient is a female, she is not currently breastfeeding and she is not pregnant (verified by a negative serum pregnancy test before the treatment period). patient
No fertility potential, defined as at least one year after menopause or having undergone ligation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
Except), or have reproductive potential but use one of the following contraceptive methods:
-Double barrier method of contraception (any two of the following methods: condom, contraceptive cotton, contraceptive diaphragm with spermicidal cream)
-Use hormonal contraceptives (oral, intravenous or transdermal absorption) at least 3 months before and during the study drug
Or intrauterine contraceptive device [IUD], and use a barrier method (condom, contraceptive cotton, contraceptive diaphragm, contraceptive with spermicide
ring).
-Use a barrier method with a partner who has removed the vas deferens (condom, contraceptive cotton, contraceptive diaphragm with spermicidal cream)
-Total prohibition of sexual intercourse during the study period (abstinence for at least one full menstrual cycle before the study began)
Contraception must be used during the entire study period and for at least 4 weeks after receiving the last dose of study drug.
4. Before entering the dose adjustment period, the patient's screening laboratory laboratory test values must meet the following requirements:
-According to the CKD Epidemiological Cooperation (EPI) formula, the estimated value is ≧30 and ≦75 mL/min/1.73m2
-UACR ≧300 and ≦3500 mg/g determined by the geometric mean of the first urine samples obtained from the screening visits in the two mornings
-Serum albumin concentration ≧3.0 g/dL
-BNP≦200 pg/mL
-The female patient's serum pregnancy test result was negative
-SBP≧110 mmHg and≦180 mmHg
-HbA1c≦12%
5. Before entering the treatment period, according to the laboratory test values of the last visit during the dose adjustment period, the patient must meet the following requirements:
-The RAS inhibitor is the maximum tolerated label dose in the past 4 weeks, without dose adjustment
-Any dose of diuretic, unless there is a medical contraindication (cyclic diuretic furosemide QD≧120 mg, or bumetanide QD≧
3.3 mg, or etaneric acid QD ≧ 150 mg, or torasemide QD ≧ 60 mg)
-UACR ≧200 and ≦3500 mg/g determined by the median value of the first urine samples obtained in the first three mornings before the first week of consultation
-SBP≧110 mmHg and≦160 mmHg
-Serum potassium concentration≦5.5 mEq/L
-The female patient's serum pregnancy test result was negative.
Exclusion Criteria
1. Patients with a history of moderate or severe edema, facial edema or mucinous edema not related to trauma 6 months before screening.
2. Receiving ring diuretic furosemide QD≧120 mg, or bumetanide QD≧3.3 mg, or etaneric acid QD≧150 milligrams
Grams, or patients with torasemide QD≧60 mg.
3. Patients with a medical history of heart failure as defined by the American College of Cardiology/American Heart Association Diagnostic and Treatment Guidelines:
Stage C: Structural heart disease with previous or current heart failure, or
Stage D: Intractable heart failure requiring special intervention.
4. Patients who are currently receiving ACEi and ARB combination drugs, rosiglitazone, aliskiren or aldosterone blockers.
5. Patients who are currently receiving pioglitazone and have edema.
2. Receiving ring diuretic furosemide QD≧120 mg, or bumetanide QD≧3.3 mg, or etaneric acid QD≧150 milligrams
Grams, or patients with torasemide QD≧60 mg.
3. Patients with a medical history of heart failure as defined by the American College of Cardiology/American Heart Association Diagnostic and Treatment Guidelines:
Stage C: Structural heart disease with previous or current heart failure, or
Stage D: Intractable heart failure requiring special intervention.
4. Patients who are currently receiving ACEi and ARB combination drugs, rosiglitazone, aliskiren or aldosterone blockers.
5. Patients who are currently receiving pioglitazone and have edema.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
150 participants
