A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

July 31, 2024 updated by: Hoffmann-La Roche

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Cemic; Haematology
      • San Juan, Argentina, J5400DIL
        • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
      • San Nicolás, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40150-150
        • Ser Servicos Especializados Em Reumatologia
    • MG
      • Belo Horizonte, MG, Brazil, 31270-901
        • Hospital das Clinicas - UFMG
      • Juiz de Fora, MG, Brazil, 36010-570
        • Centro Mineiro de Pesquisa - CMIP
    • PR
      • Curitiba, PR, Brazil, 80440-020
        • Instituto Scribner.
    • RS
      • Porto Alegre, RS, Brazil, 90480-000
        • LMK Serviços Médicos S/S
    • SP
      • Sao Paulo, SP, Brazil, 04026-000
        • Universidade Federal de Sao Paulo - UNIFES
  • Colombia
      • Barranquilla, Colombia, 080020
        • Clinica de la Costa
      • Bogota, Colombia, 000472
        • Hospital Universitario San Ignacio
      • Bogota, Colombia
        • Riesgo De Fractura; Rheumatology
      • Medellin, Colombia, 050034
        • Hospital Pablo Tobon Uribe
  • Costa Rica
      • Goicoechea, Costa Rica, 10801
        • Hospital Clinica Catolica
  • France
      • Creteil, France, 94010
        • HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
      • Lille, France, 59037
        • Hopital Claude Huriez; Internal Medicine
      • Marseille, France, 13003
        • Hopital europeen Marseille; Service de medecine interne
      • Paris, France, 75651
        • Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
      • Paris, France, 75877
        • Hopital Bichat Claude Bernard; Nephrologie
      • Toulouse, France, 31059
        • Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center; Rheumatology
      • Petach Tikva, Israel, 4941492
        • Beilinson Medical Center; Rheumatology
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center; Tel Hashomer
  • Italy
    • Piemonte
      • Torino, Piemonte, Italy, 10154
        • Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
  • Mexico
    • BAJA California
      • Mexicali, BAJA California, Mexico, 21100
        • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44620
        • Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, Tlalpan 14000
        • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
      • Mexico, D.F., Mexico CITY (federal District), Mexico, 6726
        • Hospital General De Mexico; Rheumatology
    • Michoacan
      • Morelia, Michoacan, Mexico, 58070
        • Centro de Investigación Clínica de Morelia S.C.
    • Sinaloa
      • Culiacán Rosales, Sinaloa, Mexico, 80000
        • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • Panama
      • Panama, Panama, 0801
        • Trial Labs
  • Peru
      • Lima, Peru
        • Instituto de Ginecología y Reproducción
      • Miraflores, Peru, 15074
        • Centro de Investigación Delgado; Clinica Delgado
      • San Juan de Miraflores, Peru, 15801
        • Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
      • San Martin de Porres, Peru, 15102
        • Hospital Nacional Cayetano Heredia; Rheumatology
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial; Servicio de Nefrologia
      • Malaga, Spain, 29009
        • Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Univ of California, San Diego
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory Uni ; Division of Rheumatology
    • New York
      • Brooklyn, New York, United States, 11203
        • Suny Downstate Medical Center; Rheumatology
      • Great Neck, New York, United States, 11021
        • North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University; Division of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College of Rheumatology (ACR) criteria
  • Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
  • Proteinuria (urine protein to creatinine ratio) greater than (>) 1.0
  • For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
  • For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

Exclusion Criteria:

  • Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
  • Presence of rapidly progressive glomerulonephritis
  • Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) <30 milliliters per minute (mL/min) or the need for dialysis or renal transplant
  • Greater than 50% of glomeruli with sclerosis on renal biopsy
  • Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
  • Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
  • Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude participant participation
  • Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
  • Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy within 12 months
  • Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20) within 6 months of randomization
  • Known intolerance to MMF or MPA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Drug: Mycophenolate Mofetil/Mycophenolic Acid
MMF/MPA will be administered as per schedule specified in the respective arm.
Drug: Obinutuzumab
Obinutuzumab will be administered as per schedule specified in the respective arm.
Other Names:
  • Gazyva, GA101, RO5072759
Drug: Methylprednisolone
Methylprednisolone IV will be administered as per schedule specified in the respective arm.
Drug: Prednisone
Prednisone will be administered as per schedule specified in the respective arm.
Placebo Comparator: Placebo
Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Drug: Mycophenolate Mofetil/Mycophenolic Acid
MMF/MPA will be administered as per schedule specified in the respective arm.
Drug: Methylprednisolone
Methylprednisolone IV will be administered as per schedule specified in the respective arm.
Drug: Prednisone
Prednisone will be administered as per schedule specified in the respective arm.
Other: Placebo
Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
Time Frame: From baseline to Week 52
Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN range of central laboratory values.
From baseline to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52
Time Frame: From baseline to Week 52
OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of <1.0. 2. If baseline protein:creatinine ratio is > 3.0, then urine protein:creatinine ratio of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF.
From baseline to Week 52
Percentage of Participants Who Achieve Protocol Defined CRR at Week 24
Time Frame: Week 24
CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.
Week 24
Change From Baseline in Complement Component 3 (C3) Levels at Week 52
Time Frame: Baseline and Week 52
Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.
Baseline and Week 52
Change From Baseline in C4 Levels at Week 52
Time Frame: Baseline, Week 52
Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.
Baseline, Week 52
Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52
Time Frame: Week 52
mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5.
Week 52
Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52
Time Frame: Week 52
mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.
Week 52
Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52
Time Frame: Week 52
mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5.
Week 52
Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
Time Frame: Week 0, Week 24, Week 52
Week 0, Week 24, Week 52
Systemic Clearance of Obinutuzumab
Time Frame: Day 0, Week 24, Week 52
Day 0, Week 24, Week 52
Volume of Distribution Under Steady State (Vss) of Obinutuzumab
Time Frame: Day 0, Week 24, Week 52
Day 0, Week 24, Week 52
Terminal Plasma Half-Life (t1/2) of Obinutuzumab
Time Frame: Day 0, Week 24, Week 52
Day 0, Week 24, Week 52
Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
Time Frame: Baseline (Day 1), Weeks 4, 12, 24, 36, 52
Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.
Baseline (Day 1), Weeks 4, 12, 24, 36, 52
Time to OR Over 52 Weeks
Time Frame: From baseline to Week 52
OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. Percentage of participants with response at various time points were measured using Kaplan Meier method.
From baseline to Week 52
Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52
Time Frame: Week 52
PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0.
Week 52
Time to CRR Over 52 Weeks
Time Frame: From Baseline to Week 52
CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method.
From Baseline to Week 52
Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
Time Frame: Baseline and Week 52
Anti-dsDNA antibodies are a group of anti-nuclear autoantibodies targeting double stranded DNA.
Baseline and Week 52
Percentage of Participants With Adverse Events (AEs)
Time Frame: From baseline to approximately 7 years and 8 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. The AEs reported do not include events after the receipt of rescue medications.
From baseline to approximately 7 years and 8 months
Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia
Time Frame: From baseline to approximately 7 years and 8 months
Infusion related reaction is defined as any event reported within 24 hours of infusion and thought to be causally related to the investigational agent by the investigator. Grade 3 or higher infections include all events of Grade 3 to 5 under the SOC of infections and infestations. Drug-related neutropenia is defined as events in the Roche AE Grouped Term (AEGT) "Neutropenia and associated complications" and thought to be causally related to the investigational agent by the investigator. Drug-related thrombocytopenia is defined as events in the Standard MedDRA Query (SMQ) "Haematopoietic Thrombocytopenia narrow" and thought to be causally related to the investigational agent by the investigator.
From baseline to approximately 7 years and 8 months
Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab
Time Frame: From baseline to approximately 7 years and 8 months
Antibodies are a blood protein produced in response to and counteracting a specific antigen.
From baseline to approximately 7 years and 8 months
Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 52, Week 104, B Cell Follow-Up (Bcfu) at months 6, 12, 18, 24, 30, 36, 42 and 48
CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19.
Baseline, Week 2, Week 4, Week 12, Week 24, Week 52, Week 104, B Cell Follow-Up (Bcfu) at months 6, 12, 18, 24, 30, 36, 42 and 48
Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WA29748
  • 2015-002022-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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