Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-29 @ 5:16 PM
Study NCT ID:
NCT07020832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051799', 'term': 'Delayed Graft Function'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716074', 'term': 'pegcetacoplan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to freedom from dialysis through Day 90', 'timeFrame': 'Duration of dialysis through day 90', 'description': 'To assess the efficacy of pegcetacoplan compared with that of placebo in participants at high risk of DGF following donor kidney allograft transplant surgery'}], 'secondaryOutcomes': [{'measure': 'eGFR at Week 52', 'timeFrame': '52 weeks following surgery', 'description': 'To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes'}, {'measure': 'Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)', 'timeFrame': '7 days following surgery', 'description': 'To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes'}, {'measure': 'eGFR at Day 90', 'timeFrame': '90 days following surgery', 'description': 'To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes'}, {'measure': 'Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14', 'timeFrame': '14 days following surgery', 'description': 'To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes'}, {'measure': 'Biopsy-proven rejection-free kidney allograft survival by Week 52', 'timeFrame': '52 weeks following surgery', 'description': 'To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delayed Graft Function', 'End Stage Renal Disease', 'Deceased Donor Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN ADULTS AT HIGH RISK OF DELAYED GRAFT FUNCTION (DGF) FOLLOWING KIDNEY ALLOGRAFT TRANSPLANTATION'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged at least 18 years\n2. Have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor.\n3. Be on dialysis at the time of your transplant and produce very little urine (less than 200 mL per day). You must have been on dialysis for at least 3 months.\n4. Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:\n\n 1. It cannot be due to a serious infection or a serious blood clot in your previous transplant.\n 2. Your calculated Panel Reactive Antibody (CPRA) level must be below 50%.\n5. Be getting a donor kidney that meets the study's specific requirements.\n6. Be at low to medium risk of transplant rejection, and be scheduled to receive:\n\n 1. A medication called ATG as part of your transplant procedure.\n 2. Steroids (corticosteroids) as part of your treatment at the time of screening.\n 3. A medication called tacrolimus (or a similar drug) after your transplant, according to usual medical practice.\n7. Have received certain vaccines before starting the study treatment, specifically:\n\n 1. Pneumococcal (S. pneumoniae)\n 2. Meningococcal (N. meningitidis types A, C, W, Y, and B)\n 3. Haemophilus influenzae type B\n\nIf you haven't had these vaccines, you may still qualify if you're medically shown not to respond to them and your doctor has a plan to give you preventive antibiotics, with the sponsor's approval.\n\nExclusion Criteria:\n\n1. Have taken part in another medical research study or used an experimental drug, treatment, or device in the past 30 days (or longer, depending on the drug).\n2. Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs.\n3. Weigh less than 20kg or more than 120kg at screening.\n4. Have or had recently had any of the following infections:\n\n 1. Hepatitis B or Hepatitis C (unless treated and no longer active).\n 2. HIV (human immunodeficiency virus) at any time.\n5. Have had cancer in the past 5 years, unless it was:\n\n 1. A small, treated skin cancer (like basal or squamous cell), or\n 2. A very small kidney cancer that was found early and treated.\n6. Have received any other organ transplant (except for one previous kidney transplant), or are scheduled for a transplant involving more than one organ."}, 'identificationModule': {'nctId': 'NCT07020832', 'briefTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apellis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation', 'orgStudyIdInfo': {'id': 'APL2-DGF-318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pegceptacoplan', 'description': 'Administration as a 20mL IV infusion initially, then as a subcutaneous infusion', 'interventionNames': ['Drug: Pegcetacoplan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administration as a 20mL IV infusion initially, then as a subcutaneous infusion', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pegcetacoplan', 'type': 'DRUG', 'description': 'Complement (C3) Inhibitor', 'armGroupLabels': ['Pegceptacoplan']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Sterile solution of equal volume to active arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Apellis Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@apellis.com', 'phone': '617-977-5700'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apellis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}