UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010952 |
|---|---|
| Receipt number | R000012821 |
| Scientific Title | Effects of linagliptin on diabetic nephropathy in CKD patients |
| Date of disclosure of the study information | 2013/06/13 |
| Last modified on | 2019/07/11 10:37:25 |
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Basic information
Public title
Effects of linagliptin on diabetic nephropathy in CKD patients
Acronym
Effects of linagliptin on diabetic nephropathy in CKD patients
Scientific Title
Effects of linagliptin on diabetic nephropathy in CKD patients
Scientific Title:Acronym
Effects of linagliptin on diabetic nephropathy in CKD patients
Region
| Japan |
Condition
Condition
patients with diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of linagliptin on the progression of diabetic nephropathy in CKD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of albuminuria
Key secondary outcomes
improvement of GLP-1 activity, AGEs and glucose control
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
linagliptin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetic nephropathy
Key exclusion criteria
1) diabetic ketoacidosis
2) severe infection
3) pregnancy
4) CHF, AKI
5) severe liver dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | FUKAMI |
| Middle name | |
| Last name | KEI |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine,
Zip code
830-0011
Address
67 Asahi-machi
TEL
0942-35-3311
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine,
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Nephrology, Department of Medicine, Kurume University School of Medicine
Address
67 Asahi-machi
Tel
+81942317002
fukami@med.kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
60
Results
There was no evidence of the benefit of torazenta.
Results date posted
| 2019 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
DN patients
Participant flow
IN and OUT patients
Adverse events
non
Outcome measures
renal function proteinuria
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012821
