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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003233-38 | EudraCT Number | ||
| 2023-506525-11-00 | EU Trial (CTIS) Number |
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This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Treatment: Obinutuzumab | Experimental | Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA). |
|
| Open Label Treatment: Tacrolimus | Active Comparator | Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Open Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve a Complete Remission (CR) at Week 104 | Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve an Overall Remission at Week 104 | Week 104 | |
| Percentage of Participants who Achieve CR at Week 76 | Week 76 | |
| Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94118 | United States | ||
| University of Colorado in Denver-Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42246654 | Derived | Fervenza FC, Hou FF, Hao CM, Kirsztajn GM, Gesualdo L, Hryszko T, Pisani A, Roccatello D, Bomback AS, Rae J, Barmaki F, Berisha E, Schindler T, Omachi TA, Garg JP, Malvar A; MAJESTY Trial Investigators. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026 Jun 5. doi: 10.1056/NEJMoa2602678. Online ahead of print. | |
| 37678236 |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| Tacrolimus | Drug | Open Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment. |
|
| Methylprednisolone | Drug | Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. |
|
| Acetaminophen | Drug | Premedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. |
|
| Diphenhydramine | Drug | Premedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. |
|
| Up to 8 years |
| Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline | Up to 8 years |
| Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104 | Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale. | Baseline to Week 104 |
| Duration of CR | Up to 8 years |
| Change in anti-PLA2R Autoantibody Titer | Baseline to Week 52 |
| Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104 | Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale | Baseline to Week 104 |
| Percentage of Participants with Adverse Events (AEs) | Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to 8 years |
| Percentage of Participants with AEs of Special Interest (AESIs) | AESIs are required to be reported by the investigator to the Sponsor immediately | Up to 8 years |
| Peripheral B-cell Counts at Specified Timepoints | Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 156, 182, 208 and every 26 weeks thereafter |
| Serum Concentrations of Obinutuzumab at Specified Timepoints | Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 143, 156, 169, 182, 195, 208, every 26 weeks thereafter |
| Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline | Open Label: Baseline; Escape Treatment: Week 0 |
| Incidence of ADAs during the study | Weeks 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 130, 156, 182, 208 and every 26 weeks thereafter |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Accel Research Sites; Mid-Florida Kidney and Hypertension Care | Altamonte Springs | Florida | 32701 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Nephrotex Research Group | Dallas | Texas | 75231 | United States |
| Organizacion Medica de Investigacion | Buenos Aires | C1015ABO | Argentina |
| CINME | Buenos Aires | C1056ABI | Argentina |
| Hospital Britanico Buenos Aires | Buenos Aires | C1280AEB | Argentina |
| Ser Servicos Especializados Em Reumatologia | Salvador | Estado de Bahia | 40150-150 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos | São Paulo | São Paulo | 04038-002 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Zhejiang Provincial People?s Hospital | Hangzhou | Zhejiang | 310014 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| The 1st Affiliated hospital of Fujian Medical University | Fuzhou | 350005 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | 510515 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Huashan Hospital, Fudan University | Shanghai | 200040 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430030 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Xi'an | 710061 | China |
| General Hospital of Ningxia Medical University | Yinchuan | 750004 | China |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Tenon | Paris | 75020 | France |
| Hopital Rangueil | Toulouse | 31059 | France |
| Sheba MC | Ramat Gan | 52621 | Israel |
| Policlinico di Bari | Bari | Apulia | 70124 | Italy |
| A.O. U. Federico II | Naples | Campania | 80131 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili | Brescia | Lombardy | 25123 | Italy |
| ASST Monza - Ospedale San Gerardo | Monza | Lombardy | 20900 | Italy |
| Ospedale San Giovanni Bosco | Turin | Piedmont | 10154 | Italy |
| Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego | ?ód? | 90-153 | Poland |
| Uniwersytecki Szpital Kliniczny im WAM CSW | ?ód? | 92-213 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bia?ystok | 15-276 | Poland |
| Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy | Bydgoszcz | 85-094 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroc?aw | 50-556 | Poland |
| First Moscow State Medical University n.a. I.M. Sechenov | Moscow | Moscow Oblast | 119021 | Russia |
| Rostov State Medical Uni | Rostov-on-Don | Rostov Oblast | 344022 | Russia |
| German clinic | Saint Petersburg | Sankt-Peterburg | 196070 | Russia |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hacettepe Uni School of Medicine | Ankara | 06100 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty | Antalya | 07059 | Turkey (Türkiye) |
| Ege Uni School of Medicine | Izmir | 35100 | Turkey (Türkiye) |
| Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6. |
| 33693991 | Derived | Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available. |
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D016559 | Tacrolimus |
| D008775 | Methylprednisolone |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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