Kidney TransplantationPhase 1/2NCT02417870
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
A Phase 1/2 study testing aldesleukin in people with Kidney Transplantation, run by Anil K. Chandraker, MD at 1 site in United States.
Trial summary
To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- aldesleukin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipients
- >18 years and <75 years of age
- >6 months post Tx
- on stable dose of immunosuppression
- Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
- Ability to give informed consent
Who cannot join
- Biopsy proven acute cellular rejection; greater than grade 1A
- Baseline creatinine >3.5mg/dL
- Patients with active infection, including Hepatitis B and C, HIV
- Current or prior invasive malignancy
- Patients who are pregnant or breastfeeding
- Patients who are unable to give consent
Show all 12Show fewer
- Prior intolerance of/allergy to IL2
- Inability to comply with treatment
- History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
- Symptomatic congestive cardiac failure or uncontrolled cardiac angina
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control [defined in protocol \& ICF] during study treatment, and for 6 months after completion of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation
To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.
- Conditions
- Kidney Transplantation
- Being tested
- aldesleukin
- Keywords
- Transplantation, interleukin-2, IL-2, Kidney, Renal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Also called recombinant IL-2, recombinant interleukin-2, proleukin
| Study group | Role | What they receive |
|---|---|---|
| aldesleukin | Experimental | Not described Receives: Biological: aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Treg Count
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: lack of funding/resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anil K. Chandraker, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anil K. Chandraker, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417870
- Sponsor's protocol ID
- 2015P000796
- Status last verified
- Jun 2021
- First submitted
- 13 Apr 2015
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation
- ClinicalTrials.gov ID
- NCT02417870
- Acronym / sponsor ID
- 2015P000796
- Conditions
- Kidney Transplantation
- Keywords
- Transplantation, interleukin-2, IL-2, Kidney, Renal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding/resources
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Anil K. Chandraker, MDUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aldesleukin | Experimental | Biological: aldesleukin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kidney transplant recipients
- >18 years and <75 years of age
- >6 months post Tx
- on stable dose of immunosuppression
- Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
Key exclusion criteria (12 listed)
- Biopsy proven acute cellular rejection; greater than grade 1A
- Baseline creatinine >3.5mg/dL
- Patients with active infection, including Hepatitis B and C, HIV
- Current or prior invasive malignancy
- Patients who are pregnant or breastfeeding
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 |
|---|---|---|
| aldesleukinAlso: recombinant IL-2, recombinant interleukin-2, proleukin | Biological | aldesleukin |
Primary outcome
Increase in Treg Count
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aldesleukin in people with Kidney Transplantation, run by Anil K. Chandraker, MD at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 24 Jun 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Increase in Treg Count (time frame: 6 weeks). 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 24 Jun 2021.