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Diabetic NephropathiesPhase 2NCT01200394

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

A Phase 2 study testing PF-00489791 in people with Diabetic Nephropathies, run by Pfizer at 160 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Nephropathies
What is being tested?
PF-00489791
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
160 sitesin 15 countries
Study dates
Dec 2010to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

160 sites in 15 countries.

160 sites in 15 countries

United States63 sites

  • Mountain Kidney and Hypertension Associates, PA

    Asheville, North Carolina, 28801

  • Central Texas Kidney Associates

    Austin, Texas, 78751

  • Research Management, Inc.

    Austin, Texas, 78751

  • North America Research Institute

    Azusa, California, 91702

  • North American Research Institute / California Kidney Specialist

    Azusa, California, 91702

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • Renal Remission & Hypertension Consultants, PLLC

    Bremerton, Washington, 98310

  • Chicago Clinical Research Institute, Inc.

    Chicago, Illinois, 60616

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203

  • Rockdale Medical Research Associates

    Conyers, Georgia, 30094

  • Citrus Dialysis Center

    Covina, California, 91723

  • Alzohaili Medical Consultants

    Dearborn, Michigan, 48124

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Investigative Clinical Research of Indiana, LLC

    Elwood, Indiana, 46036

  • Associates in Nephrology, SC

    Evergreen Park, Illinois, 60805

  • Research by Design, LLC

    Evergreen Park, Illinois, 60805

  • Nephrology Associates of Northern Virginia, Inc.

    Fairfax, Virginia, 22033

  • Apex Medical Research, AMR, Inc.

    Flint, Michigan, 48504

  • Apex Medical Research, MI, Inc.

    Flint, Michigan, 48504

  • AKDHC Medical Research Services, LLC*

    Glendale, Arizona, 85306

  • Carolina Nephrology, PA

    Greenville, South Carolina, 29605

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • Diagnostic Clinic of Houston, PA

    Houston, Texas, 77004

  • Houston Nephrology Research

    Houston, Texas, 77024

  • Research Across America

    Houston, Texas, 77054

  • Saadat Ansari Internal Medicine

    Huntsville, Alabama, 35801

  • The Office of Iqbal Saeed MD, LLC

    Huntsville, Alabama, 35805

  • ASA Clinical Research, LLC

    Jupiter, Florida, 33458

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • California Institute of Renal Research

    La Mesa, California, 91942

  • Alliance Against Diabetes

    Las Vegas, Nevada, 89101

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Lincoln Nephrology and Hypertension

    Lincoln, Nebraska, 68510

  • Nebraska Nephrology Research Institute, LLC - Research Management, Inc.

    Lincoln, Nebraska, 68510

  • Renal Physicians of Georgia

    Macon, Georgia, 31217

  • Nephrology Specialists, P.C.

    Mechanicsville, Virginia, 23116

  • Boise Kidney and Hypertension Institute

    Meridian, Idaho, 83642

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Palmetto Nephrology, PA

    Orangeburg, South Carolina, 29118

  • South Carolina Nephrology & Hypertension Ctr, Inc

    Orangeburg, South Carolina, 29118

  • South Carolina Nephrology and Hypertension Center

    Orangeburg, South Carolina, 29118

  • Four Rivers Clinical Research, Inc.

    Paducah, Kentucky, 42003

  • RenalCare Associates

    Peoria, Illinois, 61603

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Biolab Research, LLC

    Rockville, Maryland, 20852

  • Capital Nephrology Clinical Research

    Sacramento, California, 95825

  • Renal Associates, PA

    San Antonio, Texas, 78215

  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.

    San Antonio, Texas, 78229

  • California Kidney Specialists

    San Dimas, California, 91773

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Renal Remission and Hypertension Clinic

    Silverdale, Washington, 98383

  • Lakeview Medical Research

    Summerfield, Florida, 34491

  • Southwest Clinical Research Institute, LLC

    Tempe, Arizona, 85281

  • Southwest Clinical Research Institute, LLC

    Tempe, Arizona, 85284

  • Jacobi Medical Center - Department of Medicine - Nephrology

    The Bronx, New York, 10461

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

  • American Institute of Research

    Whittier, California, 90602

  • Whittier Internal Medicine Nephrology Medical Group

    Whittier, California, 90602

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

  • Lake Medical Research

    Willoughby Hills, Ohio, 44094

  • Trial Management Associates

    Wilmington, North Carolina, 28401

  • North Valley Nephrology

    Yuba City, California, 95991

Other trials in United States

Canada14 sites

  • Entralogix Clincal Research Inc.

    Brampton, Ontario, L6Z 4N5

  • Entralogix Clinical Research Inc.

    Brampton, Ontario, L6Z 4N5

  • Sheldon M Chumir Health Centre

    Calgary, Alberta, T2N 0X7

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Centre de sante et de services sociaux champlain-Charles-Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Centre de Dialyse de Bois de Boulogne

    Montreal, Quebec, H3M 3E3

  • Hopital de Sacre Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Entralogix Clinical Research Inc.

    Oakville, Ontario, L6J 3M5

  • Saskatoon Nephrology Group, Nurses Redisence

    Saskatoon, Saskatchewan, S7M 2Z1

  • Saskatoon Nephrology Group, Nurses Residence

    Saskatoon, Saskatchewan, S7M 2Z1

  • Saskatoon Nephrology Group

    Saskatoon, Saskatchewan, S7M 2Z1

  • N/A - formerly with Entralogix SMO

    Toronto, Ontario, M4C 5T2

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

Other trials in Canada

South Africa11 sites

  • Worthwhile Clinical Trials (WWCT), Lake View Hospital

    Benoni, Gauteng, 1500

  • Latros International

    Bloemfontein, 9301

  • Division of Nephrology and Hypertension, E13 Renal Unit

    Cape Town, 7925

  • Centre for Diabetes and Endocrinology

    Durban, KwaZulu-Natal, 4091

  • St Augustine's Hospital

    Durban, 4001

  • Centre for Diabetes and Endocrinology

    Durban, 4091

  • Centre for Diabetes and Endocrinology

    Houghton, Johannesburg, 2198

  • Wits Clinical research

    Johannesburg, Gauteng- South Africa, 2096

  • Intercare Parow Medical and Dental Centre

    Parow, 7500

  • Dr. George Mukhari Hospital -University of Limpopo

    Pretoria, Gauteng, 0204

  • Medi-Clinic Heart Hospital (Pretoria Heart Hospital)

    Pretoria, 132

Other trials in South Africa

India10 sites

  • Gujarat Kidney Foundation

    Ahmedabad, Gujarat, 380 007

  • Shrushrut Clinical Research Association

    Ahmedabad, Gujarat, 380 013

  • Apollo Hospitals

    Hyderabad, Andhra Pradesh, 500096

  • P. D. Hinduja National Hospital and Medical Research Centre

    Mumbai, Maharashtra, 400016

  • Pfizer Centre

    Mumbai, Maharashtra, 400102

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411 004

  • Diabetes Care and Research Centre

    Pune, Maharashtra, 411 011

  • KE.M Hospital Research Centre

    Pune, Maharashtra, 411 011

  • King Edward Memorial Hospital

    Pune, Maharashtra, 411 011

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, Maharashtra, 411001

Other trials in India

Poland9 sites

  • NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna

    Bielsko-Biala, 43-300

  • Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego

    Katowice, 40-027

  • NZOZ PS "Medica"

    Lublin, 20-538

  • Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow

    Warsaw, 02-256

  • Centrum Medyczne "OSTEOMED" NZOZ

    Warsaw, 02-256

  • Centrum Medyczne "Osteomed"

    Warsaw, 02-256

  • Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw

    Warsaw, 02-256

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 4749

  • SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego

    Wroclaw, 50-556

Other trials in Poland

South Korea9 sites

  • Pharmacy

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Clinical Trial Pharmacy

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center, Department of Pharmacy

    Seoul, 135-710

  • Samsung Medical Center,Sungkyunkwan Univ School of Medicine

    Seoul, 135-710

  • Samsung Medical Center/Division of Nephrology

    Seoul, 135-710

  • Boramae Medical Center/Division of Nephrology

    Seoul, 156-707

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

Malaysia7 sites

  • Clinical Research Centre, Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Unit Hemodialisis, Hospital Serdang

    Kajang, Selangor, 43000

  • Universiti Sains Malaysia

    Kota Bharu, Kelantan, 16150

  • Nephrology Clinic, Queen Elizabeth Hospital

    Kota Kinabalu, Sabah, 88586

  • Unit Kajian Klinikal, Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150,

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

Serbia6 sites

  • Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases

    Belgrade, 11 000

  • Clinic for Nephrology, Military Medical Academy

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Center "Zvezdara"

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Clinic for Endocrinology, Clinical Center Nis

    Niš, 18000

Other trials in Serbia

United Kingdom6 sites

  • Research Offices (5th Floor)

    Coventry, CV2 2DX

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire, DN2 5LT

  • University of Edinburgh

    Edinburgh, EH16 4TJ

  • The Royal London Hospital Whitechapel

    London, E1 1BB

  • Guy's and St Thomas' Foundation Trust

    London, SE1 9RT

  • Northern General Hospital Campus

    Sheffield, S5 7AU

Other trials in United Kingdom

Australia5 sites

  • Renal Research Practice

    Gosford, New South Wales, 2250

  • Department of Nephrology

    New Lambton, Newcastle, 2305

  • Pharmacy Department

    New Lambton, Newcastle, 2305

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

  • Melbourne Renal Research Group

    Reservoir, Victoria, 3073

Other trials in Australia

Hong Kong5 sites

  • Queen Mary Hospital

    Hong Kong

  • Division of Nephrology, Dept. of Medicine

    Pokfulam

  • Division of Nephrology

    Pokfulam

  • ICON Clinical Research

    Quarry Bay

  • Prince of Wales Hospital

    Shatin, N.T. 0

Other trials in Hong Kong

Mexico5 sites

  • Hospital Angeles del Pedregal

    Angeles Del Pedregal Cp., 10700

  • ICLE SC

    Guadalajara, Jalisco, 44600

  • Comite Mexicano para la Prevencion de la Osteoporosis, A.C.

    Mexico City, Mexico City, 06100

  • Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis

    San Luis Potosí City, San Luis Potosí, 78240

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)

    Tlalpan, Mexico City, 14000

Other trials in Mexico

Slovakia4 sites

  • FNsP Bratislava, Nemocnica Stare Mesto

    Bratislava, 813 69

  • Nemocnice s poliklinikami n.o.

    Levice, 934 01

  • Fakultna nemocnica s poliklinikou J.A.Reimana Presov

    Prešov, 081 81

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

Other trials in Slovakia

Denmark3 sites

  • Aarhus Universitetshospital (Aarhus Sygehus)

    Aarhus, 8000

  • Rigshospitalet

    Copenhagen Oe, 2100

  • Steno Diabetes Center

    Gentofte Municipality, 2820

Other trials in Denmark

Sweden3 sites

  • Sahlgrenska University Hospital Njurmottagningen

    Gothenburg, 413 45

  • A+ Science City site

    Stockholm, 111 57

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

About this study

Official 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

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.

Being tested
PF-00489791, Placebo
Keywords
Diabetic nephropathy, chronic kidney disease, PF-00489791, phosphodiesterase, PDE5
Medical subject headings
Diabetic Nephropathies, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00489791Drug

    Tablet, 20 mg once daily for 12 weeks

  • PlaceboDrug

    Tablet, placebo once daily for 12 weeks

Study groups in NCT01200394
Study groupRoleWhat they receive
PF-00489791ExperimentalNot described
Receives: Drug: PF-00489791
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12

    UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.

    Measured: Baseline, Week 12 (Day 5, 6, 7)

Secondary outcomes (9)

  1. Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16

    UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.

    Measured: Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)

  2. Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16

    UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.

    Measured: 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)

  3. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16

    The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).

    Measured: Baseline, Week 3, 6, 12, 16 (follow-up)

  4. Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16

    Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.

    Measured: Week 0, 3, 6, 12, 16 (follow-up)

  5. Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16

    Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).

    Measured: Baseline, Week 3, 6, 12, 16 (follow-up)

  6. Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16

    TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).

    Measured: Baseline, Week 3, 6, 12, 16 (follow-up)

  7. Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16

    The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).

    Measured: Baseline, Week 12, 16 (follow-up)

  8. Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16

    Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).

    Measured: Baseline, Week 12, 16 (follow-up)

  9. Plasma Concentration Versus Time Summary of PF-00489791

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01200394
Sponsor's protocol ID
A7331011
Other IDs
2010-021358-20
Status last verified
Feb 2019
First submitted
10 Sep 2010
Last updated
12 Mar 2019
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00489791 in people with Diabetic Nephropathies, run by Pfizer at 160 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in United States, Canada, South Africa, India, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12 (time frame: Baseline, Week 12 (Day 5, 6, 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01200394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.

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