Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
NCT ID: NCT02010242
Last Updated: 2025-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2013-10-31
2015-03-31
Brief Summary
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The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GKT137831
GKT137831 100 mg capsules twice a day
GKT137831
1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
Placebo
Placebo capsule twice a day
Placebo
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
Interventions
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GKT137831
1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
Placebo
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
Eligibility Criteria
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Inclusion Criteria
* History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL) or a glycated hemoglobin (HbA1c) \>6.5% (48 mmol/mol) on at least 2 occasions prior to screening.
* Albuminuria defined as a UACR of 300 to 3500 mg/g.
* An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
* Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.
Exclusion Criteria
* Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
* Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
* History of renal transplant or planned renal transplant during the study.
* A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes \[KDIGO\] definition) within 12 weeks of the first screening visit (Visit 1)
* HbA1c level \>11% (97 mmol/mol).
* History of hypothyroidism requiring hormone replacement therapy.
* History of active cardiovascular disease
* A personal or family history of long QT syndrome.
* Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent
18 Years
80 Years
ALL
No
Sponsors
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Calliditas Therapeutics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Wiesel, MD
Role: STUDY_DIRECTOR
Calliditas Therapeutics AB
Locations
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Advanced Arizona Clinical Research
Tucson, Arizona, United States
The Endocrine Medical Group, Inc
Orange, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Genoma Research Group, Inc.
Miami, Florida, United States
Coral Research Clinic
Miami, Florida, United States
Pines Clinical Research Inc.
Pembroke Pines, Florida, United States
Volunteer Medical Research
Port Charlotte, Florida, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Community Medical Research Partners
Indianapolis, Indiana, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
LLC DBA AccessMD Clinical Research
Dayton, Ohio, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
17070 Red Oak dr Ste 103
Houston, Texas, United States
Dialysis West University Health System
San Antonio, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Zablocki VAMC
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Deakin University school of medicine
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Baker Institute
Melbourne, Victoria, Australia
Maroondah ECRU
Ringwood East, Victoria, Australia
Captain Stirling Medical Centre
Nedlands, Western Australia, Australia
Endocrine Research Inc.
Vancouver, British Columbia, Canada
LMC Diabetes & Endocrinology
Brampton, Ontario, Canada
Clinical Research Solutions
Kitchener, Ontario, Canada
LMC Diabetes and Endocrinology
Thornhill, Ontario, Canada
Toronto East General Medical Centre
Toronto, Ontario, Canada
Medpharmgene
Montreal, Quebec, Canada
Nemocnice Havlickuv Brod
Huzová, , Czechia
Oblastni nemocnice Jicin a.s.
Nový Bydžov, , Czechia
Faculty Hospital and Palacky University Olomouc
Olomouc, , Czechia
Milan Kvapil s.r.o. diabetology ambulance
Prague, , Czechia
IKEM
Prague, , Czechia
Studienzentrum Haematologie/Onkologie/Diabeteologie
Aschaffenburg, , Germany
ZKS Suedbrandenburg GmbH
Elsterwerda, , Germany
IKFE - Institute for Clinical Research and Development
Mainz, , Germany
IDFM
München, , Germany
Centrum Badaa Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, , Poland
Medicus w Opolu sp z o.o.
Opole, , Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, , Poland
KO-MED Centra Kliniczne Sp. z o.o.
Staszów, , Poland
Department of Nephrology, Transplantationa and Internal Medicine
Szczecin, , Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, , Poland
Countries
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Other Identifiers
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GSN000200
Identifier Type: -
Identifier Source: org_study_id
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