Last reviewed · How we verify
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Phase 2 trial testing Eculizumab in Antibody Mediated Rejection in 102 participants. Terminated before completion.
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 2 November 2011 |
| Primary completion | 13 May 2014 |
| Estimated completion | 13 November 2015 |
| Sites | 41 locations across France, Italy, Netherlands, Sweden, United Kingdom, Germany, Norway, Australia |
Alexion Pharmaceuticals, Inc. — full company profile →
18 and older, any sex, with Antibody Mediated Rejection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
| Group | Value | 95% CI |
|---|---|---|
| Eculizumab | 5 | |
| Standard of Care | 7 |
Time frame: Adverse events were collected throughout the 3-year study period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Eculizumab | Standard of Care |
|---|---|---|---|
| Kidney transplant rejection | Immune system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Escherichia urinary tract infection | Infections and infestations | — | — |
| Lymphocele | Vascular disorders | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Pyelonephritis | Infections and infestations | — | — |
| Urosepsis | Infections and infestations | — | — |
| Bronchitis | Infections and infestations | — | — |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | — | — |
| Blood creatinine increased | Investigations | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Hydronephrosis | Renal and urinary disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Pancreatitis acute | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection bacterial | Infections and infestations | — | — |
| Urinary tract infection enterococcal | Infections and infestations | — | — |
| Delayed graft function | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Eculizumab | Standard of Care |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Kidney transplant rejection | Immune system disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Tremor | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| BK virus infection | Infections and infestations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Metabolic acidosis | Metabolism and nutrition disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Asthenia | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Incision site pain | Injury, poisoning and procedural complications | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Kidney transplant rejection, Diarrhoea, Urinary tract infection, Escherichia urinary tract infection, Lymphocele, Gastroenteritis, Pneumonia, Pyelonephritis.
Data from ClinicalTrials.gov NCT01399593 adverse events section.
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01399593.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing