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NCT Number: NCT00253786

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Okayama University Hospital

Okayama, 700-8558, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intensive multifactorial therapy

Other

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

Standard therapy

Other

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)

Primary outcomes

  1. Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A

    Time frame: 5 years

  2. 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

Secondary outcomes

  1. GFR in Protocol A

    Time frame: 5 years

  2. Cardiovascular event in Protocol A

    Time frame: 5 years

  3. Progression of retinopathy in Protocol A

    Time frame: 5 years

  4. Urinary albumin/creatinine ratio in Protocol A

    Time frame: 5 years

  5. Proteinuria (24 h collection sample) in Protocol A

    Time frame: 5 years

  6. GFR in Protocol B

    Time frame: 5 years

  7. Cardiovascular event in Protocol B

    Time frame: 5 years

  8. Progression of retinopathy in Protocol B

    Time frame: 5 years

  9. Urinary albumin/creatinine ratio in Protocol B

    Time frame: 5 years

  10. Urinary protein/creatinine ratio in Protocol B

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2005
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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