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SclerodermaPhase 2ZEBRANCT02047708

Zibotentan Better Renal Scleroderma Outcome Study

A Phase 2 study testing Zibotentan in people with Scleroderma and Scleroderma Renal Crisis, run by University College, London at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

Many patients with scleroderma have damage to their kidneys caused by the disease. There is limited evidence for treatments to prevent this damage or stop it progressing. Blocking a substance in the blood called endothelin has helped treat some aspects of scleroderma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zibotentan
How many people
27 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2014to Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Adults with scleroderma and:
  • CKD 2/3 (ZEBRA 1)
  • Renal crisis not on dialysis (ZEBRA 2A)
  • Renal crisis on dialysis (ZEBRA 2B)

Who cannot join

  • Previous use of an endothelin receptor antagonist within 3 months of the study start
  • Significant abnormalities in liver function testing (ALT, ALP, Bilirubin) more than three times upper limit of normal)
  • Patients with body weight <40kg.
  • Patients with conditions which prevent compliance with the protocol or failure to adhere to therapy.
  • Patients with any other life threatening condition.
  • Patients with known hypersensitivity to Zibotentan or its excipients
Show all 14Show fewer
  • Previous history of epilepsy or other CNS AEs, neurologic symptoms or signs consistent with acute or evolving spinal cord compression, and CNS metastases
  • Patients with a baseline left ventricular ejection fraction < 40% (prior to any scleroderma renal crisis), patients with acute myocardial infarction within six months or patients who are judged by the trial clinician to be at unacceptable risk from cardiac complications.
  • History of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
  • Patients receiving cyclosporin A within 1 week of screening or expecting to receive this agent during the study.
  • Patients who have received an investigational agent in the month prior to screening. These patients may be eligible if after a month of washout period, they are still within 112 months of the onset of the Scleroderma renal crisis.
  • Active malignancy or neoplastic disease in the previous 12 months
  • Women who rely on oestrogencontaining contraceptives (due to potential drug interaction with Zibotentan).
  • Females who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Free London NHS Foundation Trust

    London, NW32QG

Other trials in United Kingdom

About this study

Official title: A Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to Scleroderma

Many patients with scleroderma have damage to their kidneys caused by the disease. There is limited evidence for treatments to prevent this damage or stop it progressing. Blocking a substance in the blood called endothelin has helped treat some aspects of scleroderma. The purpose of this study is to see how effective a new endothelin blocker called Zibotentan is in treating patients who have scleroderma and have gone on to develop reduced kidney function as a complication. It will be given in addition to the accepted treatments used for scleroderma. There will be three parts to this study each for a different group of patients:

  • ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma
  • ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by scleroderma (scleroderma renal crisis) who do not require dialysis
  • ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis
Read the detailed description

This is a 3-part study (Zebra 1, 2A and 2B) that will explore safety and therapeutic potential of Zibotentan in acute and chronic renal complications of Scleroderma. Trial duration will be 52 weeks for Zebra 1 and 2A (1 or 2 weeks for ZEBRA 2B with 1 year follow up data). Scleroderma (Systemic sclerosis) is a multisystem rheumatic disease that results in vascular damage and fibrosis of target organs.This project will focus specifically on the evaluation and treatment of renal disease in scleroderma.

Renal involvement in Scleroderma occurs with a variety of different pathologies; hypertensive scleroderma renal crisis (SRC) being the most dramatic manifestation but milder forms of chronic renal disease are frequent and represent an important clinical feature.

Being tested
Zibotentan
Medical subject headings
Scleroderma, Diffuse, Renal Insufficiency, Chronic

What participants receive

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

  • ZibotentanDrug

    Also called ZD4054

    Selective endothelin-A antagonist

What is being measured

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

  1. sVCAM 1 soluble Vascular Cell Adhesion Molecule

    sVCAM1 is a biomarker of renal involvement in scleroderma

    Measured: 12 months

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2017
  4. Study completionOct 2017

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
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047708
Sponsor's protocol ID
2013-003200-39
Acronym
ZEBRA
Status last verified
Oct 2017
First submitted
22 Jan 2014
Last updated
31 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Stern EP, Host LV, Wanjiku I, Escott KJ, Gilmour PS, Ochiel R, Unwin R, Burns A, Ong VH, Cadiou H, O'Keeffe AG, Denton CP. Zibotentan in systemic sclerosis-associated chronic kidney disease: a phase II randomised placebo-controlled trial. Arthritis Res Ther. 2022 Jun 1;24(1):130. doi: 10.1186/s13075-022-02818-6.

    PubMed 35650639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zibotentan in people with Scleroderma and Scleroderma Renal Crisis, run by University College, London at 1 site in United Kingdom.

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 4 inclusion and 14 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

sVCAM 1 soluble Vascular Cell Adhesion Molecule (time frame: 12 months). 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 NCT02047708, which also lists 1 linked publication.

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 31 Oct 2017.

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