Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

July 19, 2019 updated by: Kenichi Shikata, Okayama University

Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Okayama, Japan, 700-8558
        • Okayama University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with type 2 diabetes
  2. Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
  3. Serum creatinine level: =<2.5 mg/dl
  4. Patients aged 20-75 years

Exclusion Criteria:

  1. Type 1 diabetes
  2. Hereditary diabetes or secondary diabetes
  3. Non-diabetic nephropathy
  4. Familial hypercholesterolemia
  5. Secondary hypertension
  6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
  7. Malignant tumor or life threatening disease
  8. History of angioedema
  9. Patients undergoing LDL apheresis
  10. Biliary system obstruction or severe liver injury
  11. Liver dysfunction
  12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
  13. Pregnant or nursing patients
  14. Others: patients who are not suitable for this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive multifactorial therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
Other: Intensive multifactorial therapy
Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
Active Comparator: Standard therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
Other: Standard therapy
Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
Experimental: Intensive multifactorial therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Other: Intensive multifactorial therapy
Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
Active Comparator: Standard therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Other: Standard therapy
Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A
Time Frame: 5 years
5 years
Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
GFR in Protocol A
Time Frame: 5 years
5 years
Cardiovascular event in Protocol A
Time Frame: 5 years
5 years
Progression of retinopathy in Protocol A
Time Frame: 5 years
5 years
Urinary albumin/creatinine ratio in Protocol A
Time Frame: 5 years
5 years
Proteinuria (24 h collection sample) in Protocol A
Time Frame: 5 years
5 years
GFR in Protocol B
Time Frame: 5 years
5 years
Cardiovascular event in Protocol B
Time Frame: 5 years
5 years
Progression of retinopathy in Protocol B
Time Frame: 5 years
5 years
Urinary albumin/creatinine ratio in Protocol B
Time Frame: 5 years
5 years
Urinary protein/creatinine ratio in Protocol B
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama University

Investigators

  • Principal Investigator: Hirofumi Makino, M.D., Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2005

Primary Completion (Actual)

November 27, 2014

Study Completion (Actual)

November 27, 2014

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNETT-Japan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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