Renal TransplantationPhase 3INSPIRENCT01586845
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
A Phase 3 study testing voclosporin and tacrolimus in people with Renal Transplantation, run by Aurinia Pharmaceuticals Inc..
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- voclosporin and tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-65 years inclusive at the time of screening.
- Recipients of a first or second deceased donor or living donor renal transplant.
Who cannot join
- Subjects presently receiving immunosuppression for a previously failed transplant.
- Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.
- Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control.
- Subjects receiving a HLA identical living related transplant.
- Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match.
- Subjects undergoing primary transplant with a current PRA (or CPRA) ≥ 25%.
Show all 19Show fewer
- Subjects who experienced graft loss within 1 year of transplant.
- Subjects receiving a kidney from a ABO incompatible donor.
- Subjects receiving a kidney from a deceased donor positive for HIV, HBV, HCV or tuberculosis.
- Subjects receiving a a kidney from a non-heart beating donor.
- Subjects receiving paired (en bloc or paired) kidney transplants.
- Transplantation of multiple grafts (e.g. kidney and pancreas).
- Subjects receiving a kidney with a cold ischemia time > 30 hours.
- Subjects receiving any transplanted organ other than a kidney.
- Recipients of a bone marrow or stem cell transplant.
- Any systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against CMV and/or PCP infection will be permitted).
- Subjects with positive results of the following serological tests: HIV I Ab, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and the anti-hepatitis C virus antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization.
- Subjects with active tuberculosis (Tb) requiring treatment within the last 3 years. Subjects with a known positive purified protein derivative (PPD) test are not eligible unless they have completed treatment for latent Tb and have a negative chest X-ray at time of enrollment. PPD testing must have been done within the last 12 months, and a positive result is defined as ≥ 10 mm induration, a Heaf score of >1 in non-Bacille Calmette-Guérin (BCG) immunized subjects, or >2 in BCG immunized subjects.
- Subjects with a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodessication.
About this study
Official title: A Phase III, Randomized, Multicentre, Open-Label, Concentration-Controlled, Safety and Efficacy Study of Voclosporin and Tacrolimus in Renal Transplantation
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
Read the detailed description
This will be a phase III, randomized, multicentre, open-label, concentration-controlled study in subjects undergoing a first or second renal transplant, with induction immunosuppression with an IL-2 receptor antibody (basiliximab), mycophenolate mofetil and steroids.
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
- Conditions
- Renal Transplantation
- Being tested
- voclosporin, tacrolimus
- Keywords
- Randomized Controlled Trials, Immunosuppression, Adult, Kidney Transplantation, Treatment Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voclosporinDrug
Also called voclosporin, ISA247
Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled
tacrolimusDrug
tacrolimus as per labeled dose
| Study group | Role | What they receive |
|---|---|---|
| Voclosporin | Experimental | Voclosporin Receives: Drug: voclosporin |
| Tacrolimus | Active comparator | Tacrolimus Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
FDA Efficacy Failure is biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist) where subjects who experience death, graft loss (return to dialysis for >30 days, allograft nephrectomy or re-transplantation), or lost to follow-up are included in the analysis as treatment failures. EMA Efficacy Failure includes any subject experiencing any of the following: biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist), death, graft loss or graft dysfunction (Cockcroft-Gault CrCl < 40 mL/min).
Measured: 1 Year post-Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586845
- Sponsor's protocol ID
- ISA10-12
- Acronym
- INSPIRE
- Status last verified
- Jan 2014
- First submitted
- 25 Apr 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
PubMed 21943027Kuglstatter A, Mueller F, Kusznir E, Gsell B, Stihle M, Thoma R, Benz J, Aspeslet L, Freitag D, Hennig M. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin). Acta Crystallogr D Biol Crystallogr. 2011 Feb;67(Pt 2):119-23. doi: 10.1107/S0907444910051905. Epub 2011 Jan 15.
PubMed 21245533Birsan T, Dambrin C, Freitag DG, Yatscoff RW, Morris RE. The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro. Transpl Int. 2005 May;17(12):767-71. doi: 10.1007/s00147-004-0799-z. Epub 2005 Apr 13.
PubMed 15827754
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicentre, Open-Label, Concentration-Controlled, Safety and Efficacy Study of Voclosporin and Tacrolimus in Renal Transplantation
- ClinicalTrials.gov ID
- NCT01586845
- Acronym / sponsor ID
- INSPIRE / ISA10-12
- Conditions
- Renal Transplantation
- Keywords
- Randomized Controlled Trials, Immunosuppression, Adult, Kidney Transplantation, Treatment Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
Detailed description
This will be a phase III, randomized, multicentre, open-label, concentration-controlled study in subjects undergoing a first or second renal transplant, with induction immunosuppression with an IL-2 receptor antibody (basiliximab), mycophenolate mofetil and steroids.
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voclosporin | Experimental | Drug: voclosporinVoclosporin |
| Tacrolimus | Active comparator | Drug: tacrolimusTacrolimus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 18-65 years inclusive at the time of screening.
- Recipients of a first or second deceased donor or living donor renal transplant.
Key exclusion criteria (19 listed)
- Subjects presently receiving immunosuppression for a previously failed transplant.
- Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.
- Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control.
- Subjects receiving a HLA identical living related transplant.
- Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voclosporinAlso: voclosporin, ISA247Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled | Drug | Voclosporin |
| tacrolimustacrolimus as per labeled dose | Drug | Tacrolimus |
Primary outcome
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
Time frame: 1 Year post-Transplant
FDA Efficacy Failure is biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist) where subjects who experience death, graft loss (return to dialysis for >30 days, allograft nephrectomy or re-transplantation), or lost to follow-up are included in the analysis as treatment failures. EMA Efficacy Failure includes any subject experiencing any of the following: biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist), death, graft loss or graft dysfunction (Cockcroft-Gault CrCl < 40 mL/min).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Background: PubMed 21943027Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
- Background: PubMed 21245533Kuglstatter A, Mueller F, Kusznir E, Gsell B, Stihle M, Thoma R, Benz J, Aspeslet L, Freitag D, Hennig M. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin). Acta Crystallogr D Biol Crystallogr. 2011 Feb;67(Pt 2):119-23. doi: 10.1107/S0907444910051905. Epub 2011 Jan 15.
- Background: PubMed 15827754Birsan T, Dambrin C, Freitag DG, Yatscoff RW, Morris RE. The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro. Transpl Int. 2005 May;17(12):767-71. doi: 10.1007/s00147-004-0799-z. Epub 2005 Apr 13.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing voclosporin and tacrolimus in people with Renal Transplantation, run by Aurinia Pharmaceuticals Inc..
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 2 inclusion and 19 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: withdrawn, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization. (time frame: 1 Year post-Transplant). 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 NCT01586845, which also lists 3 linked publications.
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 20 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.