Kidney Failure, ChronicPhase 1NCT02586051

A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation

A Phase 1 study testing Obinutuzumab and Intravenous Immunoglobulin in people with Kidney Failure, Chronic, run by Hoffmann-La Roche at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2) obinutuzumab infusions. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Obinutuzumab and Intravenous Immunoglobulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 9 sitesUnited States
Study dates: 19 Nov 2015to 26 Nov 2018
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ESRD with a history of sensitizing events
United network for organ sharing (UNOS) listed for a deceased donor kidney transplantation
Estimated high likelihood of receiving an offer in the coming 12-18 months from screening as evidenced by: present on at least one match run for a deceased donor kidney during the past year, or calculated panel reactive antibody (cPRA) greater than or equal to (≥) 98 percent (based on revisions to allocation policy introduced in 2014)
Female participants of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception during the treatment period and for at least 18 months after the last dose of study drug
Male participants: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 12 months after the last dose of study drug

Who cannot join

Incomplete recovery from recent major surgery or less than (<) 12 weeks since major surgery prior to baseline and participants planned surgery within 24 weeks of baseline except for kidney transplantation
Pregnant or lactating women
Positive serum human chorionic gonadotropin (hCG) measured at screening unless considered not clinically significant based on best medical judgement and if reassessment after ≥48 hours shows a less than a 2-fold rise from previous level
Primary or secondary immunodeficiency disease
Seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or seropositivity for Hepatitis C
History of active or latent tuberculosis (TB) or suspicion of active TB

Show all 19Show fewer

Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline
Currently active alcohol or drug abuse or history of alcohol or drug abuse
Participants with a history of prior kidney transplantation(s) after 6 participants with prior kidney transplants will be enrolled in the study
Participants on peritoneal dialysis with a history of peritoneal infection at any time during the 12 weeks from prior to screening
Participants on peritoneal dialysis with a positive culture or high cell count numbers on peritoneal fluid indicative of confirmed or suspected infection at the time of screening.
Participants for synchronous organ transplant
Recipients of any live attenuated vaccine(s) within 1 month of the screening visit
Abnormal screening laboratory results
Participants with a history of major cardiovascular or pulmonary disease
Use of investigational agents within 12 weeks or five half-lives of randomization
Use of an anti-CD20 therapy within the past 12 months
Known contraindications to obinutuzumab
History of severe allergic or anaphylactic reactions to monoclonal antibodies or components of obinutuzumab infusion

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin
Madison, Wisconsin, 53792
Mayo Clinic - Minnesota
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
UCSF
San Francisco, California, 94115
Stanford Health Care
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase Ib, Single- and Multiple-Dose, Open-Label Study of The Safety, Pharmacokinetics and Pharmacodynamics of Obinutuzumab in Adults With End-Stage Renal Disease and Hypersensitization Awaiting Renal Transplantation

Desensitization Period: In Cohort 1, participants will receive single dose obinutuzumab IV infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post dose for the last participant of Cohort 1, Cohort 2 will be allowed to proceed. In Cohort 2, participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period: Participants who qualify for transplantation and receive a compatible kidney offer after inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the desensitization phase and at Week 28 post-transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion.

Conditions: Kidney Failure, Chronic
Being tested: Obinutuzumab, Intravenous Immunoglobulin
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.

ObinutuzumabDrug
Also called RO5072759
Obinutuzumab 1000 milligrams (mg) IV infusion.
Intravenous ImmunoglobulinDrug
High dose (2 grams per kilogram [g/kg]) IVIG (maximum 140 grams).

Study groups in NCT02586051
Study group	Role	What they receive
Cohort 1: Single Dose Obinutuzumab	Experimental	Desensitization period: Participants will receive obinutuzumab on Day 1 followed by high dose intravenous immunoglobulin (IVIG) on Days 22 and 43 of treatment period. Transplantation period: Participants who are found to qualify for transplantation and receive a compatible kidney offer after inclusion will receive two additional infusions of obinutuzumab (one at the time of transplantation [within the first 48 hours of the transplantation] and second at Week 24 post-transplantation). Receives: Drug: Obinutuzumab; Drug: Intravenous Immunoglobulin
Cohort 2: Repeated Dose Obinutuzumab	Experimental	Desensitization period: Participants will receive obinutuzumab on Days 1 and 15 followed by high dose IVIG on Days 22 and 43. An additional dose of obinutuzumab may be administered on Day 169 at investigator's discretion. Transplantation period: Participants who are found to qualify for transplantation and receive a compatible kidney offer after inclusion will receive two additional infusions of obinutuzumab (one at the time of transplantation [within the first 48 hours of the transplantation] and second at Week 24 post-transplantation). Receives: Drug: Obinutuzumab; Drug: Intravenous Immunoglobulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants with Adverse Events
Measured: Week 0 up to Week 24 of the desensitization phase

Secondary outcomes (7)

Maximum Serum Concentration (Cmax) of Obinutuzumab During the Entire Study
Detailed timeframe:
Cohort 1: Pre-dose (0 hour [hr]); within 1 hr of end of infusion; at 24 hr post-start of infusion at Day 1; Weeks 3 and 6 (immediately prior to IVIG administration); at Weeks 1, 2, 12, 24, 36 and 52; early termination and long-term follow up visit (up to Week 76).
Cohort 2: Pre-dose (0 hr), within 1 hr of end of infusion, at 24 hr post-start of infusion at Week 0 and Week 2; immediately prior to IVIG administration at Week 3 and 6; Weeks 24 (pre-dose [0 hr] and within 1 hr of end of infusion if optional third infusion is provided); additionally at Weeks 1, 12, 36; and 52; at early termination and long-term follow-up visit (up to Week 76).
Transplantation Period (Cohorts 1 and 2) (for participants undergoing transplantation): Pre-dose (0-30 minutes) and within 1 hr of end of infusion for each obinutuzumab dose at Weeks 0 and 24), at long-term follow-up visit (Week 76). Duration of infusion: approximately 4.5 hr for 1st infusion, and 3.5 hr for subsequent infusions.
Measured: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Cmax of Obinutuzumab After the First Course of Obinutuzumab (Cmax1)
Cohort 1: Pre-dose (0 hr); within 1 hr of the end of infusion; at 24 hr post-start of infusion at Day 1; at Weeks 1, 2 Cohort 2: Pre-dose (0 hr), within 1 hour of the end of infusion, at 24 hours post-start of infusion at Week 0; Pre-dose (0 hr) at Week 2 Duration of infusion: approximately 4.5 hr.
Measured: Baseline up to Week 2 (detailed timeframe is given in outcome measure description)
Cmax of Obinutuzumab After the Second Course of Obinutuzumab (Cmax2)
Measured: Cohort 2: Pre-dose (0 hr), within 1 hour of the end of infusion, at 24 hours post-start of infusion at Week 2 Duration of infusion: approximately 3.5 hr.
Area Under the Concentration Time Curve (AUC) of Obinutuzumab
Detailed timeframe:
Cohort 1: Pre-dose (0 hr); within 1 hr of end of infusion; at 24 hr post-start of infusion at Day 1; Weeks 3 and 6 (immediately prior to IVIG administration); at Weeks 1, 2, 12, 24, 36 and 52; early termination and long-term follow up visit (up to Week 76).
Cohort 2: Pre-dose (0 hr), within 1 hr of end of infusion, at 24 hr post-start of infusion at Week 0 and Week 2; immediately prior to IVIG administration at Week 3 and 6; Weeks 24 (pre-dose [0 hr] and within 1 hr of end of infusion if optional third infusion is provided); additionally at Weeks 1, 12, 36; and 52; at early termination and long-term follow-up visit (up to Week 76).
Transplantation Period (Cohorts 1 and 2) (for participants undergoing transplantation): Pre-dose (0-30 minutes) and within 1 hr of end of infusion for each obinutuzumab dose at Weeks 0 and 24), at long-term follow-up visit (Week 76). Duration of infusion: approximately 4.5 hr for 1st infusion, and 3.5 hr for subsequent infusions.
Measured: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Systemic Clearance (CL) of Obinutuzumab
Detailed timeframe:
Cohort 1: Pre-dose (0 hr); within 1 hr of end of infusion; at 24 hr post-start of infusion at Day 1; Weeks 3 and 6 (immediately prior to IVIG administration); at Weeks 1, 2, 12, 24, 36 and 52; early termination and long-term follow up visit (up to Week 76).
Cohort 2: Pre-dose (0 hr), within 1 hr of end of infusion, at 24 hr post-start of infusion at Week 0 and Week 2; immediately prior to IVIG administration at Week 3 and 6; Weeks 24 (pre-dose [0 hr] and within 1 hr of end of infusion if optional third infusion is provided); additionally at Weeks 1, 12, 36; and 52; at early termination and long-term follow-up visit (up to Week 76).
Transplantation Period (Cohorts 1 and 2) (for participants undergoing transplantation): Pre-dose (0-30 minutes) and within 1 hr of end of infusion for each obinutuzumab dose at Weeks 0 and 24), at long-term follow-up visit (Week 76). Duration of infusion: approximately 4.5 hr for 1st infusion, and 3.5 hr for subsequent infusions.
Measured: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Volume of Distribution at Steady State (Vss) of Obinutuzumab
Detailed timeframe:
Cohort 1: Pre-dose (0 hr); within 1 hr of end of infusion; at 24 hr post-start of infusion at Day 1; Weeks 3 and 6 (immediately prior to IVIG administration); at Weeks 1, 2, 12, 24, 36 and 52; early termination and long-term follow up visit (up to Week 76).
Cohort 2: Pre-dose (0 hr), within 1 hr of end of infusion, at 24 hr post-start of infusion at Week 0 and Week 2; immediately prior to IVIG administration at Week 3 and 6; Weeks 24 (pre-dose [0 hr] and within 1 hr of end of infusion if optional third infusion is provided); additionally at Weeks 1, 12, 36; and 52; at early termination and long-term follow-up visit (up to Week 76).
Transplantation Period (Cohorts 1 and 2) (for participants undergoing transplantation): Pre-dose (0-30 minutes) and within 1 hr of end of infusion for each obinutuzumab dose at Weeks 0 and 24), at long-term follow-up visit (Week 76). Duration of infusion: approximately 4.5 hr for 1st infusion, and 3.5 hr for subsequent infusions.
Measured: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Half-life (t1/2) of Obinutuzumab
Detailed timeframe:
Cohort 1: Pre-dose (0 hr); within 1 hr of end of infusion; at 24 hr post-start of infusion at Day 1; Weeks 3 and 6 (immediately prior to IVIG administration); at Weeks 1, 2, 12, 24, 36 and 52; early termination and long-term follow up visit (up to Week 76).
Cohort 2: Pre-dose (0 hr), within 1 hr of end of infusion, at 24 hr post-start of infusion at Week 0 and Week 2; immediately prior to IVIG administration at Week 3 and 6; Weeks 24 (pre-dose [0 hr] and within 1 hr of end of infusion if optional third infusion is provided); additionally at Weeks 1, 12, 36; and 52; at early termination and long-term follow-up visit (up to Week 76).
Transplantation Period (Cohorts 1 and 2) (for participants undergoing transplantation): Pre-dose (0-30 minutes) and within 1 hr of end of infusion for each obinutuzumab dose at Weeks 0 and 24), at long-term follow-up visit (Week 76). Duration of infusion: approximately 4.5 hr for 1st infusion, and 3.5 hr for subsequent infusions.
Measured: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201526 Nov 2018

First posted26 Oct 2015 (estimated)
Study start19 Nov 2015
Primary completion26 Nov 2018
Study completion26 Nov 2018

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 Failure, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02586051
Sponsor's protocol ID: WT29749
Status last verified: Jan 2020
First submitted: 23 Oct 2015
Last updated: 29 Jan 2020
Results posted: No
FDA-regulated drug: Yes

Publications

Redfield RR, Jordan SC, Busque S, Vincenti F, Woodle ES, Desai N, Reed EF, Tremblay S, Zachary AA, Vo AA, Formica R, Schindler T, Tran H, Looney C, Jamois C, Green C, Morimoto A, Rajwanshi R, Schroeder A, Cascino MD, Brunetta P, Borie D. Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant. Am J Transplant. 2019 Nov;19(11):3035-3045. doi: 10.1111/ajt.15514. Epub 2019 Jul 23.
PubMed 31257724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Single- and Multiple-Dose, Open-Label Study of The Safety, Pharmacokinetics and Pharmacodynamics of Obinutuzumab in Adults With End-Stage Renal Disease and Hypersensitization Awaiting Renal Transplantation
ClinicalTrials.gov ID: NCT02586051
Acronym / sponsor ID: WT29749
Conditions: Kidney Failure, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 19 Nov 2015 (actual)
Primary completion: 26 Nov 2018 (actual)
Study completion: 26 Nov 2018 (actual)
First posted: 26 Oct 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Single Dose Obinutuzumab	Experimental	Drug: Obinutuzumab, Drug: Intravenous ImmunoglobulinDesensitization period: Participants will receive obinutuzumab on Day 1 followed by high dose intravenous immunoglobulin (IVIG) on Days 22 and 43 of treatment period. Transplantation period: Participants who are found to qualify for transplantation and receive a compatible kidney offer after inclusion will receive two additional infusions of obinutuzumab (one at the time of transplantation [within the first 48 hours of the transplantation] and second at Week 24 post-transplantation).
Cohort 2: Repeated Dose Obinutuzumab	Experimental	Drug: Obinutuzumab, Drug: Intravenous ImmunoglobulinDesensitization period: Participants will receive obinutuzumab on Days 1 and 15 followed by high dose IVIG on Days 22 and 43. An additional dose of obinutuzumab may be administered on Day 169 at investigator's discretion. Transplantation period: Participants who are found to qualify for transplantation and receive a compatible kidney offer after inclusion will receive two additional infusions of obinutuzumab (one at the time of transplantation [within the first 48 hours of the transplantation] and second at Week 24 post-transplantation).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

ESRD with a history of sensitizing events
United network for organ sharing (UNOS) listed for a deceased donor kidney transplantation
Estimated high likelihood of receiving an offer in the coming 12-18 months from screening as evidenced by: present on at least one match run for a deceased donor kidney during the past year, or calculated panel reactive antibody (cPRA) greater than or equal to (≥) 98 percent (based on revisions to allocation policy introduced in 2014)
Female participants of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception during the treatment period and for at least 18 months after the last dose of study drug
Male participants: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 12 months after the last dose of study drug

Key exclusion criteria (19 listed)

Incomplete recovery from recent major surgery or less than (<) 12 weeks since major surgery prior to baseline and participants planned surgery within 24 weeks of baseline except for kidney transplantation
Pregnant or lactating women
Positive serum human chorionic gonadotropin (hCG) measured at screening unless considered not clinically significant based on best medical judgement and if reassessment after ≥48 hours shows a less than a 2-fold rise from previous level
Primary or secondary immunodeficiency disease
Seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or seropositivity for Hepatitis C

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
ObinutuzumabAlso: RO5072759Obinutuzumab 1000 milligrams (mg) IV infusion.	Drug	Cohort 1: Single Dose Obinutuzumab, Cohort 2: Repeated Dose Obinutuzumab
Intravenous ImmunoglobulinHigh dose (2 grams per kilogram [g/kg]) IVIG (maximum 140 grams).	Drug	Cohort 1: Single Dose Obinutuzumab, Cohort 2: Repeated Dose Obinutuzumab

Primary outcome

Percentage of Participants with Adverse Events
Time frame: Week 0 up to Week 24 of the desensitization phase

7 secondary outcomes

Maximum Serum Concentration (Cmax) of Obinutuzumab During the Entire Study
Time frame: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Cmax of Obinutuzumab After the First Course of Obinutuzumab (Cmax1)
Time frame: Baseline up to Week 2 (detailed timeframe is given in outcome measure description)
Cmax of Obinutuzumab After the Second Course of Obinutuzumab (Cmax2)
Time frame: Cohort 2: Pre-dose (0 hr), within 1 hour of the end of infusion, at 24 hours post-start of infusion at Week 2 Duration of infusion: approximately 3.5 hr.
Area Under the Concentration Time Curve (AUC) of Obinutuzumab
Time frame: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Systemic Clearance (CL) of Obinutuzumab
Time frame: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Volume of Distribution at Steady State (Vss) of Obinutuzumab
Time frame: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)
Half-life (t1/2) of Obinutuzumab
Time frame: Baseline up to last follow up (up to 76 weeks post-transplantation) (detailed timeframe is given in outcome measure description)

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 29 Jan 2020.
Derived from this study: PubMed 31257724Redfield RR, Jordan SC, Busque S, Vincenti F, Woodle ES, Desai N, Reed EF, Tremblay S, Zachary AA, Vo AA, Formica R, Schindler T, Tran H, Looney C, Jamois C, Green C, Morimoto A, Rajwanshi R, Schroeder A, Cascino MD, Brunetta P, Borie D. Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant. Am J Transplant. 2019 Nov;19(11):3035-3045. doi: 10.1111/ajt.15514. Epub 2019 Jul 23.

Related trials for Kidney Failure, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

Clinical Trials study director

Hoffmann-La Roche

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Obinutuzumab and Intravenous Immunoglobulin in people with Kidney Failure, Chronic, run by Hoffmann-La Roche at 9 sites 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 5 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: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Percentage of Participants with Adverse Events (time frame: Week 0 up to Week 24 of the desensitization phase). 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 NCT02586051, 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 29 Jan 2020.