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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
Date last updated
12/03/2019

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
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United States of America
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Alabama
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Arizona
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Michigan
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Nis
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Levice
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Presov
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Rimavska Sobota
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Kwazulu Natal
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Durban
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Coventry
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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
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
Trial website
https://clinicaltrials.gov/study/NCT01200394
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01200394