Bosutinib For Autosomal Dominant Polycystic Kidney Disease

NCT01233869 | Completed Phase 2 Results DMC

• 3 other identifiers: B18710193160A7-22112010-023017-65
• Study Type: interventional
• Target: 172
• Locations: 17 countries
• Sites: 67

Brief Summary

This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.

Conditions

Polycystic Kidney, Autosomal Dominant

Keywords

Bosutinib; Autosomal Dominant Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25

  TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).

  Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])

Secondary Outcomes (17)

• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination

  Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination

• Time to First Occurrence or Worsening of Hypertension

  Baseline up to Month 25 (end of ITPV)

• Time to First Occurrence or Worsening of Back and/or Flank Pain

  Baseline up to Month 25 (end of ITPV)

• Time to First Occurrence of Gross Hematuria

  Baseline up to Month 25 (end of ITPV)

• Time to First Occurrence of Proteinuria

  Baseline up to Month 25 (end of ITPV)

Other Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 30 days after last study drug administration

• Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

  Baseline up to 30 days after last study drug administration

• Number of Participants With Potentially Clinically Significant Vital Signs Findings

  Baseline up to 30 days after last study drug administration

Study Arms (3)

Cohort A

EXPERIMENTAL

Drug: Bosutinib

Cohort B

EXPERIMENTAL

Drug: Bosutinib

Cohort C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bosutinib DRUG

Once daily oral dose of 200 mg of bosutinib

Cohort A

Placebo DRUG

Once daily oral dose of placebo

Cohort C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, 18 to 50 years old at the time of consent.
• Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
• Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.

You may not qualify if:

• eGFR \< 60 mL/min/1.73m2.
• Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
• Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (67)

Southwest Kidney Institute, PLC

Phoenix, Arizona, 85004, United States

Location

Southwest Clinical Research Institute, LLC

Tempe, Arizona, 85284, United States

Location

Southwest Kidney Institute, PLC

Tempe, Arizona, 85284, United States

Location

Capital Nephrology Clinical Research

Sacramento, California, 95825, United States

Location

Boise Kidney & Hypertension Institute, PLLC

Caldwell, Idaho, 83605, United States

Location

Boise Kidney & Hypertension Institute, PLLC

Meridian, Idaho, 83642, United States

Location

Renal Associates of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University - HHC CTSI Clinical Research Center

New York, New York, 10016, United States

Location

Doylestown Hospital MRI

Doylestown, Pennsylvania, 18901, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Nephrology/Hypertension Specialists

Doylestown, Pennsylvania, 18901, United States

Location

Renal Associates, PA

San Antonio, Texas, 78215, United States

Location

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

San Antonio, Texas, 78229, United States

Location

University of Virginia Health System - Nephrology

Charlottesville, Virginia, 22908, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

The Polyclinic

Seattle, Washington, 98104, United States

Location

Renal Remission and Hypertension Clinic

Silverdale, Washington, 98383, United States

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Klinika gerontologicka a metabolicka

Hradec Králové, 500 05, Czechia

Location

Krajska nemocnice Liberec

Liberec, 460 63, Czechia

Location

Nemocnice Nove Mesto na Morave

Nové Město na Moravě, 592 31, Czechia

Location

Fakultni poliklinika VFN

Prague, 128 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Pharmaceutical Research Associates CZ, s.r.o.

Prague, 170 00, Czechia

Location

PRA Magyarorszag Kft. Klinikai Farmakologiai Vizsgalohely

Budapest, 1077, Hungary

Location

Fovarosi Onkormanyzat Szent Imre Korhaz BSZMI Klinikai Farmakologiai Reszlege

Budapest, 1115, Hungary

Location

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont I.sz.Belgyogyaszati Klinika

Szeged, 6720, Hungary

Location

Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

Location

A.O. Universitaria Ospedali Riuniti di Foggia

Foggia, 71100, Italy

Location

Vilnius University Hospital Santariskiu Clinic, Public Institution, Centre of Nephrology

Vilnius, 08661, Lithuania

Location

Spitalul Clinic Republican

Chisinau, 2025, Moldova

Location

Zaklad Diagnostyki Chorob Serca, II Katedra Kardiologii

Gdansk, 80-210, Poland

Location

Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych

Gdansk, 80-952, Poland

Location

Specjalistyczny Szpital Zachodni im. Jana Pawla II w Grodzisku Mazowieckim

Grodzisk Mazowiecki, 05-825, Poland

Location

Krakowskie Centrum Medyczne NZOZ

Krakow, 31-501, Poland

Location

Klinika Nefrologii, Hipertensjologii i Chorob Wewnetrznych Katedry Chorob Wewnetrznych UWM

Olsztyn, 10-561, Poland

Location

Pracownia Echokardiografii, Oddzial Kardiologii

Olsztyn, 10-561, Poland

Location

Centrum Medyczne Aesculap

Radom, 26-600, Poland

Location

Klinika Kardiologii

Szczecin, 70-111, Poland

Location

Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych

Szczecin, 70-111, Poland

Location

Szpital Powiatowy w Wolominie

Wołomin, 05-200, Poland

Location

SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego

Wroclaw, 50-556, Poland

Location

Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea

Oradea, Jud. Bihor, 410469, Romania

Location

Spitalul Clinic Dr. C. I. Parhon Iasi

Iași, Jud. Iasi, 700503, Romania

Location

Institutul Clinic Fundeni, Centrul de Medicina Interna-Nefrologie

Bucharest, 022328, Romania

Location

SPITALUL CLINIC JUDETEAN DE URGENTA TIMISOARA ,Clinica de Nefrologie

Timișoara, 300736, Romania

Location

Univerzitna nemocnica Bratislava

Limbova 5, Bratislava Region, 83305, Slovakia

Location

SUMMIT CLINICAL RESEARCH, s.r.o., Oddelenie internej mediciny a klinickej farmakologie

Bratislava, 831 01, Slovakia

Location

Seoul National University Hospital, Department of Internal Medicine

Seoul, 110-744, South Korea

Location

Samsung Medical Center/Division of Nephrology

Seoul, 135-710, South Korea

Location

Eulji General Hospital

Seoul, 139-872, South Korea

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Sahlgrenska Universitetssjukhuset, Njurmedicin

Gothenburg, 413 45, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76, Sweden

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

Istanbul University, Istanbul Tip Fakultesi

Istanbul, Capa, 34390, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Hastanesi Ic Hastaliklari Anabilim Dali

Izmir, Inciralti/ Narlidere, 35340, Turkey (Türkiye)

Location

Morriston Hospital

Swansea, Wales, SA6 6NL, United Kingdom

Location

BHF Glasgow Cardiovascular Research Centre, University of Glasgow

Glasgow, G12 8TA, United Kingdom

Location

Renal and Urology Directorate, Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Related Publications (2)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

• Tesar V, Ciechanowski K, Pei Y, Barash I, Shannon M, Li R, Williams JH, Levisetti M, Arkin S, Serra A. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2017 Nov;28(11):3404-3413. doi: 10.1681/ASN.2016111232. Epub 2017 Aug 24.

  PMID: 28838955 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 3, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 11, 2016
• Results First Posted: October 28, 2015

Record last verified: 2016-02

Locations

GB (3); CH (1); CZ (6); HU (3); KR (3); LI (1); IT (2); TU (2); SE (3); AU (1); US (20); PL (11); CA (2); ES (2); MO (1); SL (2); RO (4)