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Nephropathy In Type 2 Diabetes and Cardio-renal Events (NID-2)

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ClinicalTrials.gov Identifier: NCT00535925
Recruitment Status : Completed
First Posted : September 27, 2007
Results First Posted : May 11, 2020
Last Update Posted : August 3, 2020
Information provided by (Responsible Party):
Ferdinando Carlo Sasso, MD, PhD, University of Campania "Luigi Vanvitelli"

Brief Summary:

The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:

Phase 1(observational study, completed in September 2005): after the identification of a type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of renal and cardiovascular events during a middle term follow-up.

Phase 2(interventional study, started in October 2005): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: SoC therapy Drug: irbesartan Drug: ramipril Drug: hydrochlorothiazide Drug: furosemide Drug: amlodipine Drug: atenolol Drug: doxazosin Drug: clonidine Drug: insulin Drug: simvastatin Drug: fibrate Drug: erythropoietin Drug: aspirin Phase 4

Detailed Description:
The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
Actual Study Start Date : October 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard of Care (SoC) therapy
Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.
Drug: SoC therapy
the patients have to be treated according the standard good medical practice by any center

Experimental: Multifactorial Intensified therapy

An intensive multifactorial intervention according Scientific Guidelines is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.

In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg).

Drug: irbesartan

Therapy for hypertension:

- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die

Drug: ramipril

Therapy for hypertension:

- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die

Drug: hydrochlorothiazide

Therapy for hypertension

- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)

Drug: furosemide

Therapy for hypertension

- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)

Drug: amlodipine

Therapy for hypertension

- Step 3: amlodipine up to 10 mg/die

Drug: atenolol

Therapy for hypertension

- Step 4: atenolol up to 100 mg/die

Drug: doxazosin

Therapy for hypertension

- Step 5: doxazosin up to 4 mg/die

Drug: clonidine

Therapy for hypertension

- Step 6: clonidine

Drug: insulin

Therapy for Hyperglycaemia (to achieve HbA1c <7):

- insulin

Drug: simvastatin

Therapy for hypercholesterolemia:

- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die

Drug: fibrate

Therapy for hypertriglyceridemia

- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate

Drug: erythropoietin

Treatment of anaemia:

- erythropoietin

Drug: aspirin

Antiplatelet therapy (in all patients without contraindications):

- aspirin up to 160 mg/die

Primary Outcome Measures :
  1. "Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)" [ Time Frame: 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase) ]
    number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias.

Secondary Outcome Measures :
  1. "Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase" [ Time Frame: 13 years ]
    Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetic patients
  • albumin extraction rate (AER= >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months
  • diabetic retinopathy
  • patients followed in the outpatients clinic for at least 12 months

Exclusion Criteria:

  • type 1 diabetic patients
  • <40 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535925

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Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy
Naples, Italy, I-80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Study Director: Ferdinando C Sasso, MD, PhD Università della Campania "Luigi Vanvitelli", Naples, Italy
Principal Investigator: Roberto Minutolo, MD, MD Università della Campania "Luigi Vanvitelli", Naples, Italy
Study Chair: Luca De Nicola, MD, MD Università della Campania "Luigi Vanvitelli", Naples, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ferdinando Carlo Sasso, MD, PhD, AssociateProfessor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT00535925    
Other Study ID Numbers: 246813579
First Posted: September 27, 2007    Key Record Dates
Results First Posted: May 11, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by Ferdinando Carlo Sasso, MD, PhD, University of Campania "Luigi Vanvitelli":
type 2 diabetes
cardiovascular (CV) events
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Epoetin Alfa
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents