NCT01252056

Brief Summary

The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
353

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Typical duration 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

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

2.8 years

First QC Date

April 21, 2010

Last Update Submit

May 7, 2013

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • nephropathy development

    After 96-week treatment, compare the efficacy between Probucol group and group control group on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival)

    96W

Secondary Outcomes (4)

  • IMT

    48 and 96W

  • Atherosclerosis related biomarkers

    48 and 96W

  • Nephropathy development

    48 and 96W

  • Adverse events

    96W

Study Arms (3)

Control

NO INTERVENTION

Probucol

ACTIVE COMPARATOR

Probucol treatment

Drug: Probucol

Combination

ACTIVE COMPARATOR

Probucol and Cilostazol

Drug: Probucol and Cilostazol

Interventions

ProbucolDRUG

250mg,Bid

Probucol
Probucol and CilostazolDRUG

50-100mg,Bid

Combination

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 40\~75 years old
  • Type 2 diabetes mellitus above 6 months
  • HbA1c ≤8%
  • Twice (above 2-week interval) confirmed urinary albumin at 30-3000µg/mg.cre
  • Receive routine dosage ACEI or ARB treatment above 2 months, and the dosage has been fixed for at least 1 month
  • LDL-C\>100 mg/dL (2.60 mmol/L) and/ or hyperlipidemia patients with Statins treatment
  • Free will to sign the informed consent form

You may not qualify if:

  • Has an allergic history to investigational drugs
  • Receive antilipemic agents (except Statins) within the latest 2 months, including Probucol
  • Receive antiplatelet or anticoagulation agents (except Aspirin) within the latest 2 months, including Cilostazol
  • Rapid progression of nephropathy within the latest 3 months
  • Kidney disease caused by other reasons according to medical history
  • Serum potassium level less than 3.5 mEq/L or more than 5.5 mEq/L
  • Hemorrhagic tendency or hemorrhagic disease (such as alimentary tract hemorrhage, active fundus hemorrhage, etc.)
  • Has a myocardial infarction, angina pectoris, or cerebral infarction within the latest 3 months
  • Congestive heart failure
  • Pregnant, potentially pregnant, or lactating woman
  • Severe hepatic inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range)
  • Serum creatinine level is 1.5 times higher than the upper limit of the normal value range
  • Persistent or hardly controlled hypertension (such as malignant hypertension, SBP≥170 mmHg and/ or DBP≥100 mmHg)
  • Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
  • Has a medical history of cardiac syncope or primary syncope
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Universuty First Hospital

Beijng, Beijing Municipality, China

Location

Related Publications (1)

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PMID: 35224730DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

ProbucolCilostazol

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Xiaohui Guo

    Beijing University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2010

First Posted

December 2, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations

CN(1)