Trial · NCT00535925

Nephropathy In Type 2 Diabetes and Cardio-renal Events

NCT00535925, Phase 4, Completed, University of Campania Luigi Vanvitelli; results first posted 2020-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nephropathy In Type 2 Diabetes and Cardio-renal Events. Trials, record NCT00535925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00535925

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nephropathy In Type 2 Diabetes and Cardio-renal Events
NCT number: NCT00535925
Status: Completed
Phases: Phase 4
Enrollment: 850 participants, actual
Lead sponsor: University of Campania Luigi Vanvitelli
Conditions: Diabetic Nephropathy
Interventions: SoC therapy, irbesartan, ramipril, hydrochlorothiazide, furosemide, amlodipine, atenolol, doxazosin, clonidine, insulin, simvastatin, fibrate, erythropoietin, aspirin
First posted: 2007-09-27
Last updated: 2020-08-03
Results first posted: 2020-05-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"	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	"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"	13 years	Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)	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 reported will be at the end of the whole study period (follow-up) due to the fact that number needed to treat (NNT) at end of intervention was not reached)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase	13 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)	Conventional Therapy	146	Participants
Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)	Intensified Therapy	116	Participants
Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase	Standard of Care (SoC) Therapy	150	Participants
Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase	Multifactorial Intensified Therapy	191	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Conventional Therapy	188
Overall Study	STARTED	Intensified Therapy	207
Overall Study	COMPLETED	Conventional Therapy	169
Overall Study	COMPLETED	Intensified Therapy	199
Overall Study	NOT COMPLETED	Conventional Therapy	19
Overall Study	NOT COMPLETED	Intensified Therapy	8

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypoglycemia	Metabolism and nutrition disorders	Conventional Therapy	1	188	1
other	Hypoglycemia	Metabolism and nutrition disorders	Intensified Therapy	3	207	3
other	Hypotension	General disorders	Conventional Therapy	2	188	2
other	Hypotension	General disorders	Intensified Therapy	2	207	2
other	End Stage Renal Disease	Renal and urinary disorders	Conventional Therapy	2	188	2
other	End Stage Renal Disease	Renal and urinary disorders	Intensified Therapy	3	207	3
serious	Acute Myocardial Infarction	Cardiac disorders	Conventional Therapy	44	188	44
serious	Acute Myocardial Infarction	Cardiac disorders	Intensified Therapy	32	207	32
serious	stroke	Cardiac disorders	Conventional Therapy	28	188	28
serious	stroke	Cardiac disorders	Intensified Therapy	19	207	19

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Conventional Therapy	103	188
Total, all-cause mortality	Intensified Therapy	86	207
Total, other adverse events	Conventional Therapy	5	188
Total, other adverse events	Intensified Therapy	8	207
Total, serious adverse events	Conventional Therapy	88	188
Total, serious adverse events	Intensified Therapy	69	207

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16505495	BACKGROUND	PubMed
16877970	BACKGROUND	PubMed
27733159	DERIVED	PubMed
34271948	DERIVED	PubMed
36344978	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Conventional Therapy vs Intensified Therapy: Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)	Trial comparisons
Multifactorial Intensified Therapy vs Standard of Care (SoC) Therapy: Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase	Trial comparisons
Conventional Therapy vs Intensified Therapy: deaths from any cause	Trial comparisons
Conventional Therapy vs Intensified Therapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00535925

GET https://conductscience.org/api/trials/v1/NCT00535925/registered

API reference For AI assistants