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CompletedNCT02047708ZEBRAUpdated Oct 31, 2017

Zibotentan Better Renal Scleroderma Outcome Study

A Phase 2 interventional study of Zibotentan in Scleroderma, Scleroderma Renal Crisis and Chronic Kidney Disease, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by University College, London · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Scleroderma
  • Scleroderma Renal Crisis
  • Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 27 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Previous use of an endothelin receptor antagonist within 3 months of the study start
  2. Significant abnormalities in liver function testing (ALT, ALP, Bilirubin) more than three times upper limit of normal)
  3. Patients with body weight \<40kg.
  4. Patients with conditions which prevent compliance with the protocol or failure to adhere to therapy.
  5. Patients with any other life threatening condition.
  6. Patients with known hypersensitivity to Zibotentan or its excipients
  7. Previous history of epilepsy or other CNS AEs, neurologic symptoms or signs consistent with acute or evolving spinal cord compression, and CNS metastases
  8. 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.
  9. History of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
  10. Patients receiving cyclosporin A within 1 week of screening or expecting to receive this agent during the study.
  11. 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.
  12. Active malignancy or neoplastic disease in the previous 12 months
  13. Women who rely on oestrogencontaining contraceptives (due to potential drug interaction with Zibotentan).
  14. Females who are pregnant or breastfeeding.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Interventions

  • DrugZibotentan

    Selective endothelin-A antagonist

    Also known as: ZD4054

06

What researchers measure

Primary outcomes

  1. sVCAM 1 soluble Vascular Cell Adhesion Molecule

    sVCAM1 is a biomarker of renal involvement in scleroderma

    Time frame: 12 months

07

Study locations

1 site
  • Royal Free London NHS Foundation Trust
    London, NW32QG, United Kingdom
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02047708
Lead sponsor
University College, London
Collaborators
Medical Research Council
Responsible party
Sponsor
First posted
Jan 28, 2014
Start date
Oct 2014
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Oct 31, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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