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This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study. |
|
| Group 2 | Other | No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegcetacoplan | Drug | Complement (C3) Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Keck School of Medicine, University of Southern California |
The study consisted of 2 parts: Part A core study (controlled and non-controlled portion) and Part B long-term extension. A total of 13 subjects were enrolled in the study. Results are presented based on DCO date of 19 January 2024 for Part A. Subjects who experienced clinical benefit from pegcetacoplan administration could participate in part B, a long-term extension, to continue receiving pegcetacoplan until it is commercially available for the disease under study.
This phase 2, open-label study was conducted in subjects with post-transplant recurrence of complement 3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN) at 23 sites across 11 countries. First subject was recruited on 07 September 2021 and data cut-off (DCO) date was 19 January 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Controlled Portion: Group 1 | Subjects received pegcetacoplan 1080 milligram (mg) twice weekly via subcutaneous (SC) infusion on Day 1 and Day 4 of each treatment week until Week 12. |
| FG001 | Part A: Controlled Portion: Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: Controlled: Weeks 1 to 12 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Jan 15, 2025 |
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| Baseline (Day 1) and Week 52 |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented. | Baseline (Day 1), Week 12 and Week 52 |
| Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52 | Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Change From Baseline in Serum Creatinine Concentration at Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Percentage Change From Baseline in Serum Creatinine Concentration at Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | Baseline (Day 1) and Week 52 |
| Los Angeles |
| California |
| 900033 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University, St.Louis | St Louis | Missouri | 63110 | United States |
| NYU Langone Health Transplant Insitute | New York | New York | 10016 | United States |
| CUIMC | New York | New York | 10032 | United States |
| Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner | San Juan Bautista | Buenos Aires | B1888AAE | Argentina |
| Hospital Universitario Fundacion Favaloro | Buenos Aires | C1093AAS | Argentina |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Monash Medical Centre | Clayton | 3168 | Australia |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP | Botucatu | São Paulo | 18618-686 | Brazil |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | CEP 30150-221 | Brazil |
| Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
| Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology | Lille | 59000 | France |
| Hopital Edouard Herriot, Hospices Civils de Lyon | Lyon | 69437 | France |
| Center Hospitalier Universitaire de Montpellier | Montpellier | 34295 CEDEX 5 | France |
| Istituto di Ricerche Farmacologiche Mario Negri IRCCS | Ranica | 24020 | Italy |
| Radbound University Medical Center | Nijmegen | 6500 HB | Netherlands |
| Hospital Universitario 12 de Octubre, Nephrology Department | Madrid | 28041 | Spain |
| CHUV | Lausanne | 1005 | Switzerland |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
Subjects did not receive any pegcetacoplan treatment until Week 12. |
| FG002 | Part A: Non-controlled Portion: Group 1 | Subjects who received pegcetacoplan in Part A controlled portion: Group 1 continued to receive pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy. |
| FG003 | Part A: Non-controlled Portion: Group 2 | Subjects who did not receive pegcetacoplan in Part A controlled portion: Group 2 received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy. |
| COMPLETED | Subjects completed Part A (controlled portion). |
|
| NOT COMPLETED |
|
| Part A: Non-controlled: Weeks 13 to 52 |
|
|
The intent-to-treat (ITT) population included all subjects who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Controlled Portion: Group 1 | Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12. |
| BG001 | Part A: Controlled Portion: Group 2 | Subjects did not receive any pegcetacoplan treatment until Week 12. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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 | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented. | The ITT population included all subjects who were randomized. | Posted | Count of Participants | Participants | No | Baseline (Day 1), Week 12 and Week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. | Posted | Number | Percentage of participants | Baseline (Day 1) and Week 52 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52 | Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. | Posted | Number | Percentage of participants | Baseline (Day 1) and Week 52 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | milliliter/minute/1.73 square meter | Baseline (Day 1) and Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) and Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine Concentration at Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline (Day 1) and Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Serum Creatinine Concentration at Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) and Week 52 |
|
|
Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days.
The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Controlled Portion: Group 1 | Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12. | 0 | 10 | 5 | 10 | 7 | 10 |
| EG001 | Part A: Controlled Portion: Group 2 | Subjects did not receive any pegcetacoplan treatment until Week 12. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Part A: Non-controlled Portion: Group 1 | Subjects who received pegcetacoplan in Part A controlled portion: Group 1 continued to receive pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52, post Week 12 renal biopsy. | 0 | 10 | 5 | 10 | 8 | 10 |
| EG003 | Part A: Non-controlled Portion: Group 2 | Subjects who did not receive pegcetacoplan in Part A controlled portion: Group 2 received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52, post Week 12 renal biopsy. | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Renal tubular disorder | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Genital herpes simplex | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDra 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Genital herpes simplex | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Polyomavirus viraemia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDra 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDra 25.1 | Systematic Assessment |
| |
| Loss of bladder sensation | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Infusion site rash | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| New onset diabetes after transplantation | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDra 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 25.1 | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDra 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Apellis Clinical Trial Information Line | Apellis Pharmaceuticals, Inc | 1-833-284-6361 | clinicaltrials@apellis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2024 | Jan 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
Not provided
Not provided
Not provided
| Physician Decision |
|
| Male |
|
| Not reported |
|
| Not Hispanic or Latino |
|
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