NCT00810732

Brief Summary

This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Geographic Reach
1 country

2 active sites

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

May 9, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2009

Completed
14.3 years until next milestone

Results Posted

Study results publicly available

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

December 17, 2008

Results QC Date

August 4, 2022

Last Update Submit

August 4, 2022

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseSitaxsentan

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6

    Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.

    Baseline, Week 6

Secondary Outcomes (2)

  • Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6

    Baseline, Week 3 and 6

  • Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6

    Baseline, Week 3 and 6

Study Arms (3)

Sitaxsentan

EXPERIMENTAL

Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)

Drug: Open

Nifedipine

ACTIVE COMPARATOR

Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)

Drug: Nifedipine

Placebo

PLACEBO COMPARATOR

Placebo for sitaxsentan, orally administered once daily (double blind arm)

Drug: Placebo

Interventions

OpenDRUG

Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)

Also known as: Sitaxsentan
Sitaxsentan
NifedipineDRUG

Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)

Nifedipine
PlaceboDRUG

Placebo for sitaxsentan, orally administered once daily (double blind arm)

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

You may not qualify if:

  • Required peritoneal dialysis or haemodialysis.
  • Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Centre and Pharmacology Unit

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

the University of Edinburgh, Western General Hospital, Department of Medical Sciences

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (5)

  • Farrah TE, Anand A, Gallacher PJ, Kimmitt R, Carter E, Dear JW, Mills NL, Webb DJ, Dhaun N. Endothelin Receptor Antagonism Improves Lipid Profiles and Lowers PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in Patients With Chronic Kidney Disease. Hypertension. 2019 Aug;74(2):323-330. doi: 10.1161/HYPERTENSIONAHA.119.12919. Epub 2019 Jun 10.

    PMID: 31177906DERIVED

  • Dhaun N, Yuzugulen J, Kimmitt RA, Wood EG, Chariyavilaskul P, MacIntyre IM, Goddard J, Webb DJ, Corder R. Plasma pro-endothelin-1 peptide concentrations rise in chronic kidney disease and following selective endothelin A receptor antagonism. J Am Heart Assoc. 2015 Mar 23;4(3):e001624. doi: 10.1161/JAHA.114.001624.

    PMID: 25801761DERIVED

  • Dhaun N, Moorhouse R, MacIntyre IM, Melville V, Oosthuyzen W, Kimmitt RA, Brown KE, Kennedy ED, Goddard J, Webb DJ. Diurnal variation in blood pressure and arterial stiffness in chronic kidney disease: the role of endothelin-1. Hypertension. 2014 Aug;64(2):296-304. doi: 10.1161/HYPERTENSIONAHA.114.03533.

    PMID: 24890823DERIVED

  • Dhaun N, Melville V, Blackwell S, Talwar DK, Johnston NR, Goddard J, Webb DJ. Endothelin-A receptor antagonism modifies cardiovascular risk factors in CKD. J Am Soc Nephrol. 2013 Jan;24(1):31-6. doi: 10.1681/ASN.2012040355. Epub 2012 Dec 14.

    PMID: 23243212DERIVED

  • Dhaun N, MacIntyre IM, Kerr D, Melville V, Johnston NR, Haughie S, Goddard J, Webb DJ. Selective endothelin-A receptor antagonism reduces proteinuria, blood pressure, and arterial stiffness in chronic proteinuric kidney disease. Hypertension. 2011 Apr;57(4):772-9. doi: 10.1161/HYPERTENSIONAHA.110.167486. Epub 2011 Feb 28.

    PMID: 21357275DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

sitaxsentanNifedipine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

May 9, 2007

Primary Completion

March 6, 2009

Study Completion

March 6, 2009

Last Updated

July 6, 2023

Results First Posted

July 6, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

GB(2)