Kidney TransplantationPhase 1NCT02878616
Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316
A Phase 1 study testing LFG316 and IVIG in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- LFG316 and IVIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2016to 19 Jul 2017
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women 18-70 years of age suffering from end-stage renal disease and who are on chronic dialysis therapy.
- Candidates for kidney transplantation who are pre-sensitized and will be undergoing desensitization therapy.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Recipients who are ABO compatible with donor allograft.
- Patients awaiting kidney allograft from a living or deceased donor. For patients awaiting transplant from a living donor, kidney transplantation must only occur after 28 days post-LFG316 infusion.
- History of vaccination with meningococcus and pneumococcus between 2 weeks and 36 months prior to dosing. Documentation is required. If patients have not been vaccinated, they must be vaccinated at least 2 weeks prior to dosing. The choice of vaccine(s) should take into account the serotypes prevalent in the geographic areas in which study patients will be enrolled.
Who cannot join
- Patients requiring or undergoing peritoneal dialysis.
- Patients with a known contraindication to treatment with blood products.
- Patients with a known pro-thrombotic disorder and/or history of thrombosis or hyper-coagulable state, excluding hemodialysis venous access clotting.
- Patients who have positive PCR results for hepatitis B and/or hepatitis C, and/or history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Patients at risk for tuberculosis (TB)
- Patients with any severe, progressive or uncontrolled acute or chronic medical condition not related to end-stage renal disease (such as uncontrolled infectious disease or sepsis), clinical laboratory abnormalities at screening or baseline that in the investigator's opinion would make the patient inappropriate for entry into this study, or known active presence of malignancies.
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- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, unless highly effective methods of contraception are used during dosing and for 50 days after the last dose of LFG316, or sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 50 days after the last dose of LFG316.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Los Angeles, California, 90048
About this study
Official title: Open-label, Parallel-group, Drug-drug Interaction Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316
Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation
- Conditions
- Kidney Transplantation
- Being tested
- LFG316, IVIG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFG316Drug
LFG316 single dose
IVIGDrug
IVIG single dose
| Study group | Role | What they receive |
|---|---|---|
| LFG316 + IVIG | Experimental | Not described Receives: Drug: LFG316; Drug: IVIG |
| LFG316 alone | Experimental | Not described Receives: Drug: LFG316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetics (PK) of LFG316: Area Under the Plasma Concentration-time Curve (AUC)
The following PK parameters were determined from the plasma concentration time profile of LFG316 using a non-compartmental method:
AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
AUCinf: Area under the plasma concentration-time curve from time zero to infinity
Measured: 1 month
Plasma Pharmacokinetics (PK) of LFG316: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Measured: 1 month
Secondary outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start26 Aug 2016
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878616
- Sponsor's protocol ID
- CLFG316B2101
- Status last verified
- Jul 2018
- First submitted
- 22 Aug 2016
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Jordan SC, Kucher K, Bagger M, Hockey HU, Wagner K, Ammerman N, Vo A. Intravenous immunoglobulin significantly reduces exposure of concomitantly administered anti-C5 monoclonal antibody tesidolumab. Am J Transplant. 2020 Sep;20(9):2581-2588. doi: 10.1111/ajt.15922. Epub 2020 May 13.
PubMed 32301258
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Parallel-group, Drug-drug Interaction Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316
- ClinicalTrials.gov ID
- NCT02878616
- Acronym / sponsor ID
- CLFG316B2101
- Conditions
- Kidney Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 25 Aug 2016 (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.
Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFG316 + IVIG | Experimental | Drug: LFG316, Drug: IVIG |
| LFG316 alone | Experimental | Drug: LFG316 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men or women 18-70 years of age suffering from end-stage renal disease and who are on chronic dialysis therapy.
- Candidates for kidney transplantation who are pre-sensitized and will be undergoing desensitization therapy.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Recipients who are ABO compatible with donor allograft.
Key exclusion criteria (9 listed)
- Patients requiring or undergoing peritoneal dialysis.
- Patients with a known contraindication to treatment with blood products.
- Patients with a known pro-thrombotic disorder and/or history of thrombosis or hyper-coagulable state, excluding hemodialysis venous access clotting.
- Patients who have positive PCR results for hepatitis B and/or hepatitis C, and/or history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Patients at risk for tuberculosis (TB)
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 |
|---|---|---|
| LFG316LFG316 single dose | Drug | LFG316 + IVIG, LFG316 alone |
| IVIGIVIG single dose | Drug | LFG316 + IVIG |
Primary outcome
Plasma Pharmacokinetics (PK) of LFG316: Area Under the Plasma Concentration-time Curve (AUC)
Time frame: 1 month
The following PK parameters were determined from the plasma concentration time profile of LFG316 using a non-compartmental method: AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUCinf: Area under the plasma concentration-time curve from time zero to infinity
Plasma Pharmacokinetics (PK) of LFG316: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Time frame: 1 month
1 secondary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 32301258Jordan SC, Kucher K, Bagger M, Hockey HU, Wagner K, Ammerman N, Vo A. Intravenous immunoglobulin significantly reduces exposure of concomitantly administered anti-C5 monoclonal antibody tesidolumab. Am J Transplant. 2020 Sep;20(9):2581-2588. doi: 10.1111/ajt.15922. Epub 2020 May 13.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Results for CLFG316B2101 can be found on Novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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 study testing LFG316 and IVIG in people with Kidney Transplantation, run by Novartis Pharmaceuticals 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 7 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: finished, as of the sponsor's last update on 11 Dec 2020. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma Pharmacokinetics (PK) of LFG316: Area Under the Plasma Concentration-time Curve (AUC) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT02878616, which also lists 1 linked publication.
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 11 Dec 2020.