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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01200394




Registration number
NCT01200394
Ethics application status
Date submitted
10/09/2010
Date registered
13/09/2010

Titles & IDs
Public title
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Scientific title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
Secondary ID [1] 0 0
2010-021358-20
Secondary ID [2] 0 0
A7331011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathies 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-00489791
Treatment: Drugs - Placebo

Experimental: PF-00489791 -

Placebo comparator: Placebo -


Treatment: Drugs: PF-00489791
Tablet, 20 mg once daily for 12 weeks

Treatment: Drugs: Placebo
Tablet, placebo once daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
Timepoint [1] 0 0
Baseline, Week 12 (Day 5, 6, 7)
Secondary outcome [1] 0 0
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Timepoint [1] 0 0
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Secondary outcome [2] 0 0
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Timepoint [2] 0 0
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Secondary outcome [3] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Timepoint [3] 0 0
Baseline, Week 3, 6, 12, 16 (follow-up)
Secondary outcome [4] 0 0
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Timepoint [4] 0 0
Week 0, 3, 6, 12, 16 (follow-up)
Secondary outcome [5] 0 0
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Timepoint [5] 0 0
Baseline, Week 3, 6, 12, 16 (follow-up)
Secondary outcome [6] 0 0
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Timepoint [6] 0 0
Baseline, Week 3, 6, 12, 16 (follow-up)
Secondary outcome [7] 0 0
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
Timepoint [7] 0 0
Baseline, Week 12, 16 (follow-up)
Secondary outcome [8] 0 0
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Timepoint [8] 0 0
Baseline, Week 12, 16 (follow-up)
Secondary outcome [9] 0 0
Plasma Concentration Versus Time Summary of PF-00489791
Timepoint [9] 0 0
Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6

Eligibility
Key inclusion criteria
* Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
* Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
* Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
* Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
* Subjects on combination ACE inhibitor/ARB therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
256
Recruitment in Australia
Recruitment state(s)
NSW,NewcastleVIC
Recruitment hospital [1] 0 0
Renal Research Practice - Gosford
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
Department of Nephrology - New Lambton
Recruitment hospital [4] 0 0
Pharmacy Department - New Lambton
Recruitment hospital [5] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
3073 - Reservoir
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Canada
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Alberta
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Canada
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Ontario
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Quebec
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Canada
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Saskatchewan
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Aarhus
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Denmark
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Copenhagen Oe
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Denmark
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Gentofte
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Hong Kong
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Hong Kong
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Hong Kong
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Pokfulam
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Hong Kong
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Quarry Bay
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Shatin
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India
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Andhra Pradesh
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India
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Gujarat
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India
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Maharashtra
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seongnam-si
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Seoul
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Malaysia
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Sabah
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Malaysia
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Selangor
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DF
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Mexico
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Jalisco
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Mexico CITY
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Mexico
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San Luis
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Mexico
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Angeles Del Pedregal Cp.
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Bielsko-Biala
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Katowice
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Lublin
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Wroclaw
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Serbia
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Belgrade
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Serbia
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Nis
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Slovakia
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Bratislava
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Slovakia
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Levice
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Slovakia
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Presov
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Slovakia
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Rimavska Sobota
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South Africa
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Gauteng- South Africa
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South Africa
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Gauteng
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South Africa
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Kwazulu Natal
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Houghton, Johannesburg
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Parow
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South Africa
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Pretoria
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Sweden
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Goteborg
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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South Yorkshire
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Coventry
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Edinburgh
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London
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01200394