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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK090316-01A1 | U.S. NIH Grant/Contract | View source |
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Voluntarily terminated by PI due to lack of feasibility.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.
A total of 60 patients will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Active Comparator | Participants will receive Rituximab post within 24 of Kidney Transplant |
|
| No rituximab | No Intervention | Participants will not receive Rituximab within 24 hours of Kidney Transplant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Induction therapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach. | between post-transplant day 3 and day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach. | Post-Transplant Months 3-12 |
| Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Alessia Fornoni, M.D. | University of Miami | Principal Investigator |
| George W. Burke, M.D. | University of Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Participants will receive Rituximab post within 24 of Kidney Transplant Rituximab: Induction therapy |
| FG001 | No Rituximab | Participants will not receive Rituximab within 24 hours of Kidney Transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Participants will receive Rituximab post within 24 of Kidney Transplant Rituximab: Induction therapy |
| BG001 | No Rituximab | Participants will not receive Rituximab within 24 hours of Kidney Transplant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach. | Intent-to-Treat Analysis | Posted | Geometric Mean | Standard Error | ratio | between post-transplant day 3 and day 30 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | Participants will receive Rituximab post within 24 of Kidney Transplant Rituximab: Induction therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | Pneumonia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal GGT | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George W. Burke, M.D. | University of Miami | 3053555315 | gburke@med.miami.edu |
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula |
| 12 months post-transplant |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach. | Intent-to-Treat Analysis | Posted | Geometric Mean | Standard Error | ratio | Post-Transplant Months 3-12 |
|
|
|
|
| Secondary | Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) | Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula | Intent-to-Treat Analysis | Posted | Mean | Standard Error | ml/min/1.73 m^2 | 12 months post-transplant |
|
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| 11 |
| 15 |
| EG001 | No Rituximab | Participants will not receive Rituximab within 24 hours of Kidney Transplant | 0 | 15 | 0 | 15 | 13 | 15 |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | Pulmonary Edema |
|
| Acute Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute T Cell Mediated Rejection | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ascites | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bilateral Carpal Tunnel | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| BK Virus Replication | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| C-Diff Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decrease Vision | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Elevated Creatinine | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Evacuation of Subcapsular Hematoma | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flu Like Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Upset | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Generalized Body Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Generalized Edema | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Scrotal Edema | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Edema Extremeties | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bilateral Lower Extremities Edema | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Legs Edema | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Tubular Necrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hematuria | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hemorrhoids | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercoagulability | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypocapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mouth Ulcers | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Motor Vehicle Accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain at Incision Site Radiating to Scrotal Area | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Phimosis | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Post Surgical Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| CMV Viremia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Steal Syndrome | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swollen Right Lower Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swollen Right Upper Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| T-Cell and Antibody Mediated Acute Rejection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Leak | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal Yeast Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Viral Syndrome | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting and Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Worsening Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Worsening Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Worsening Hyperglycemia | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wound Infection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |