UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058718 |
|---|---|
| Receipt number | R000067142 |
| Scientific Title | Efficacy of Comprehensive Therapy, Including Pharmacotherapy and Dietary/Lifestyle Guidance, on Renoprotection in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2025/08/10 |
| Last modified on | 2025/08/06 21:34:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Comprehensive Therapy, Including Pharmacotherapy and Dietary/Lifestyle Guidance, on Renoprotection in Patients with Chronic Kidney Disease
Acronym
Efficacy of Comprehensive Therapy in Patients with Chronic Kidney Disease
Scientific Title
Efficacy of Comprehensive Therapy, Including Pharmacotherapy and Dietary/Lifestyle Guidance, on Renoprotection in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Efficacy of Comprehensive Therapy in Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether newly approved drugs, administered as monotherapy or in combination, demonstrate an effect in preventing the progression of CKD. Furthermore, this study will examine if the addition of dietary and lifestyle guidance enhances this suppressive effect. We will also assess whether the efficacy of these treatments can be confirmed in patients with advanced-stage CKD, a population typically excluded from previous clinical trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint will be the rate of decline in renal function (annual change in eGFR), and we will evaluate the change in the eGFR slope before and after the initiation of the intervention.
Key secondary outcomes
To assess for cardiovascular (CVD) events during the follow-up period, as well as changes in albuminuria and/or proteinuria.
Additional assessments include body weight and laboratory tests, such as a complete blood count (CBC) with differential, electrolytes (Na, K, Cl), minerals (P, Ca), total protein (TP), albumin (Alb), and C-reactive protein (CRP).
We will also evaluate changes in exercise and dietary habits resulting from lifestyle guidance, and assess for frailty.
Furthermore, we will investigate whether the primary cause of the chronic kidney disease is associated with any of these outcomes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 diagnosed with CKD at our institution, as well as those who were diagnosed at a previous institution and subsequently referred to us.
Key exclusion criteria
1, Individuals judged by the principal investigator to be unsuitable for the study.
2. Individuals who decline to participate in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Maruyama |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
maruyama.takashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University Itabashi Hospital, Clinical Research Judging Committee.
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
med.rinsyokenkyu@nihon-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
| 2025 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with CKD will be administered medication or/and receive dietary and lifestyle guidance. After a one-year to certain years periods, their renal function parameters will be assessed and compared with the baseline values.
Management information
Registered date
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067142
