Kidney TransplantationPhase 4NCT04404127
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
A Phase 4 study testing Basiliximab 20 milligram [Simulect] and Normal Saline in people with Kidney Transplantation, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Background: Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated Aims: To compare different induction therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Basiliximab 20 milligram [Simulect] and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2020to May 2025
- Phase
- Phase 4
- 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
- • Male or female ≥ 18 years
- Living donor
- Low immunological risk (defined as):
- First (primary) transplant
- ≤ 4 antigen mismatches (HLA matching scheme)
- Negative HLA Ab screening
Who cannot join
- • High immunological risk
- HLA identical or zero mismatched transplants
- Receiving cyclosporin as primary maintenance immunosuppressant
- Human immunodeficiency virus (HIV) co-infection
- Pregnant or nursing female
- Has received an investigational medication within the past 30 days
Show all 9Show fewer
- Has a known contraindication to the administration of Basiliximab
- Suspected or known to have a serious infection
- Multi-organ transplant
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital and Research Centre (KFSHRC)
Riyadh, 11211
Aziza Ajlan, B.Sc. Pharm. BCPS, 966114647272 ext. 80341, aajlan@kfshrc.edu.sa
Aziza Ajlan, B.Sc. Pharm. BCPS
About this study
Official title: Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
Background:
Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Read more
Aims:
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)
Methods:
Prospective, randomized, double blind, non-inferiority, controlled clinical trial
Expected Outcomes:
- Primary outcomes: Biopsy proven acute rejection within first year following transplant
- Secondary outcomes:
- Patient and graft survival at 1 year
- Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
- Emergence of de novo donor specific antibodies (DSAs)
- Conditions
- Kidney Transplantation
- Being tested
- Basiliximab 20 milligram [Simulect], Normal Saline
- Keywords
- basiliximab, Rejection, De no vo donor specific antibodies, Low immunological risk, Induction
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basiliximab 20 milligram [Simulect]Drug
Basiliximab
Normal SalineOther
No-Induction
| Study group | Role | What they receive |
|---|---|---|
| No induction Arm | Placebo comparator | Not described Receives: Other: Normal Saline |
| Induction with basiliximab | Active comparator | Not described Receives: Drug: Basiliximab 20 milligram [Simulect] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of biopsy proven acute rejection within first year following transplant
Measured: 1 year after transplant
Secondary outcomes (3)
Rate of graft survival at 1 year
Measured: 1 year after transplant
Rate of decline in eGFR at 6 months and at 12 months
Measured: 1 year after transplant
Rate of emergence of de novo donor specific antibodies (DSAs)
Measured: 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Sep 2020
- Primary completionMay 2023 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aziza Ajlan, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404127
- Sponsor's protocol ID
- RAC # 2191177
- Status last verified
- Feb 2021
- First submitted
- 19 May 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04404127
- Acronym / sponsor ID
- RAC # 2191177
- Conditions
- Kidney Transplantation
- Keywords
- basiliximab, Rejection, De no vo donor specific antibodies, Low immunological risk, Induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 May 2020 (actual)
- 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.
Background:
Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Aims:
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)
Methods:
Prospective, randomized, double blind, non-inferiority, controlled clinical trial
Expected Outcomes:
- Primary outcomes: Biopsy proven acute rejection within first year following transplant
- Secondary outcomes:
- Patient and graft survival at 1 year
- Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
- Emergence of de novo donor specific antibodies (DSAs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No induction Arm | Placebo comparator | Other: Normal Saline |
| Induction with basiliximab | Active comparator | Drug: Basiliximab 20 milligram [Simulect] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Male or female ≥ 18 years
Key exclusion criteria (9 listed)
- • High immunological risk
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 |
|---|---|---|
| Basiliximab 20 milligram [Simulect]Basiliximab | Drug | Induction with basiliximab |
| Normal SalineNo-Induction | Other | No induction Arm |
Primary outcome
Rate of biopsy proven acute rejection within first year following transplant
Time frame: 1 year after transplant
3 secondary outcomes
Rate of graft survival at 1 year
Time frame: 1 year after transplant
Rate of decline in eGFR at 6 months and at 12 months
Time frame: 1 year after transplant
Rate of emergence of de novo donor specific antibodies (DSAs)
Time frame: 1 year after transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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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.
King Faisal Specialist Hospital and Research Centre (KFSHRC)
Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Basiliximab 20 milligram [Simulect] and Normal Saline in people with Kidney Transplantation, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of biopsy proven acute rejection within first year following transplant (time frame: 1 year after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.