End Stage Renal DiseasePhase 2/3SimulectNCT00928811
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
A Phase 2/3 study testing basiliximab in people with End Stage Renal Disease, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- basiliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2010
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-75
- First kidney transplant from a living or deceased donor
- Receiving CNI and MPA
- Able to tolerate full dose MPA
- Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
- Able to tolerate renal graft biopsies
- Provided written, informed consent
- Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first Simulect administration
Who cannot join
- Known hypersensitivity to Simulect
- Current preformed PRA>10%
- Multi organ or second kidney transplant
- Use of any investigational immunosuppressive drug within 1 month of inclusion
- Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
- Known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
Show all 11Show fewer
- HBV, HCV, or HIV positive patients
- Current severe infection
- Receiving an organ from an extended criteria donor per United Network for Organ Sharing (UNOS) guidelines
- Dialysis dependent one month post transplant
- Live too far away from the transplant center for adequate follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.
Read the detailed description
The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).
- Conditions
- End Stage Renal Disease
- Being tested
- basiliximab
- Keywords
- Simulect, de novo kidney transplant subjects, calcineurin inhibitors, Prograf
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiliximabDrug
Also called Simulect
Simulect 20 mg intravenously day of transplant and day 4
basiliximabDrug
Also called Simulect (basiliximab)
Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4. Receives: Drug: basiliximab |
| Simulect | Experimental | Simulect (basiliximab) intravenously day of transplant and day 4.
Chronic Simulect (basiliximab) administration monthly for one year duration.
Concomitant decrease in Prograf administration. Receives: Drug: basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Measured: one year
Secondary outcomes (7)
To describe the pharmacokinetics of Simulect over the study course.
Measured: one year
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
Measured: one year
To assess the difference in calculated and measured GFR.
Measured: one year
To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.
Measured: one year
To assess the difference in vital signs and lab abnormalities
Measured: one year
To determine the difference in incidence and severity of albuminuria/proteinuria
Measured: one year
To collect safety data on infections and malignancies
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Investigator left University 04/2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, cynthia gifford, Drexel University
- Investigators
- Mysore Anil S. Kumar, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928811
- Sponsor's protocol ID
- 17718
- Other IDs
- CHI 621A
- Acronym
- Simulect
- Status last verified
- Feb 2015
- First submitted
- 25 Jun 2009
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
- ClinicalTrials.gov ID
- NCT00928811
- Acronym / sponsor ID
- Simulect / 17718
- Conditions
- End Stage Renal Disease
- Keywords
- Simulect, de novo kidney transplant subjects, calcineurin inhibitors, Prograf
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left University 04/2010
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Jun 2009 (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 study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.
Detailed description
The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: basiliximabStandard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4. |
| Simulect | Experimental | Drug: basiliximabSimulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18-75
- First kidney transplant from a living or deceased donor
- Receiving CNI and MPA
- Able to tolerate full dose MPA
- Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
Key exclusion criteria (11 listed)
- Known hypersensitivity to Simulect
- Current preformed PRA>10%
- Multi organ or second kidney transplant
- Use of any investigational immunosuppressive drug within 1 month of inclusion
- Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
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 |
|---|---|---|
| basiliximabAlso: SimulectSimulect 20 mg intravenously day of transplant and day 4 | Drug | Control |
| basiliximabAlso: Simulect (basiliximab)Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration. | Drug | Simulect |
Primary outcome
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Time frame: one year
7 secondary outcomes
To describe the pharmacokinetics of Simulect over the study course.
Time frame: one year
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
Time frame: one year
To assess the difference in calculated and measured GFR.
Time frame: one year
To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.
Time frame: one year
To assess the difference in vital signs and lab abnormalities
Time frame: one year
To determine the difference in incidence and severity of albuminuria/proteinuria
Time frame: one year
To collect safety data on infections and malignancies
Time frame: one year
Results and safety
The study was stopped early (reason given: Investigator left University 04/2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Mysore Anil S. Kumar, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing basiliximab in people with End Stage Renal Disease, run by Drexel University College of Medicine 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 8 inclusion and 11 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 10 Feb 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: Investigator left University 04/2010). Results are not available in the source record.
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?
To evaluate the risk of sensitization against the chimeric antibody, Simulect. (time frame: one year). 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 10 Feb 2015.