NCT00566033

Brief Summary

Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency. Test whether a multi-method intensive intervention including clinical Audit improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic renal insufficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
788

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

5.6 years

First QC Date

November 29, 2007

Last Update Submit

January 27, 2012

Conditions

Renal Insufficiency

Keywords

AUDITChronic kidney diseaseClinical trialCreatinineMultiple interventsNephrology guidelines.

Outcome Measures

Primary Outcomes (1)

  • A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.

    3 years

Secondary Outcomes (1)

  • The primary renal unit-level outcome is the percentage of performance targets achieved. The primary patient-level outcome is the percentage of patients for whom the recommended process measures occurs.

    3 years

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Audit-driven intervention

2

NO INTERVENTION

Patients in this arm (arm 2) will undergo to standard care.

Interventions

Audit-driven interventionBEHAVIORAL

Patients included in this arm will undergo to the multi-method quality improvement intervention (intensive intervention) that adds practice visits, telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination and feedback on demand used in the less intensive intervention.

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Creatinine \>1.5 -4.0 mg/dL (males) and \>1.3-3.5 mg/dL (females).
  • Age range :18 - 75 years

You may not qualify if:

  • Transplanted
  • Pregnant
  • Affected by cancer or diseases in the terminal phase
  • Non acute or rapidly evolving renal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Units participating to the MAURO study in the

Calabrian, Sicily, Puglia and Sardenia Regions, Italy

Location

Related Publications (4)

  • Hayward RS. Clinical practice guidelines on trial. CMAJ. 1997 Jun 15;156(12):1725-7. No abstract available.

    PMID: 9220924BACKGROUND

  • De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int. 2006 Feb;69(3):538-45. doi: 10.1038/sj.ki.5000085.

    PMID: 16395261BACKGROUND

  • Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998 May 9;316(7142):1455. doi: 10.1136/bmj.316.7142.1455. No abstract available.

    PMID: 9572764BACKGROUND

  • Leonardis D, Mallamaci F, Enia G, Postorino M, Tripepi G, Zoccali C; MAURO Study Investigators. The MAURO study: baseline characteristics and compliance with guidelines targets. J Nephrol. 2012 Nov-Dec;25(6):1081-90. doi: 10.5301/jn.5000239.

    PMID: 23172127DERIVED

MeSH Terms

Conditions

Renal InsufficiencyRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carmine Zoccali, Prof.

    CNR-IBIM & Nephrology Unit of Reggio Calabria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

January 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

IT(1)