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The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sirolimus + Daclizumab + Mycophenolate + Corticosteroids |
|
| 2 | Active Comparator | Cyclosporine + Mycophenolate + Corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus | Drug | 15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Creatinine Clearance Rate | Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Acute Rejection | The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy. | 3 and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Norway, Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo | N-0027 | Norway | ||||
Prior to enrollment in study, patients were screened for eligibility. If eligibility criteria were met, patients were enrolled and randomized.
Patients were recruited in Sweden from November 2004 to September 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus | Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
| FG001 | Cyclosporine (CsA) | Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus | Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Mean Creatinine Clearance Rate | Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function. | All patients who completed 12 months of study drug. | Posted | Jul 2009 | Mean | Standard Deviation | ml/min | 12 months |
|
Not provided
Not provided
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 | Sirolimus | Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
Not provided
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D000077561 | Daclizumab |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cyclosporine | Drug | Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12 |
|
| mycophenolate mofetil | Drug | 1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events |
|
| corticosteroids | Drug | As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day |
|
| daclizumab | Drug | IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation |
|
| Patient and Graft Survival | Graft survival is measured by graft loss which is defined as removal of the transplant. | 12 months |
| Mean Creatinine Clearance Rate - 3 Months | Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function. | 3 months |
| Gothenburg |
| SE-413 45 |
| Sweden |
| Uppsala | SE-751 85 | Sweden |
| Lack of Efficacy |
|
| Procedural complications |
|
| BG001 | Cyclosporine (CsA) | Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Cyclosporine (CsA) | Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. |
|
|
|
| Secondary | Number of Patients With Acute Rejection | The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy. | All patients who received at least one dose of study drug. | Posted | Jul 2009 | Number | patients | 3 and 12 months |
|
|
|
| Secondary | Patient and Graft Survival | Graft survival is measured by graft loss which is defined as removal of the transplant. | All patients who received at least one dose of study drug. | Posted | Jul 2009 | Number | patients | 12 months |
|
|
|
| Secondary | Mean Creatinine Clearance Rate - 3 Months | Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function. | All patients who completed 3 months of study drug. | Posted | Jul 2009 | Mean | Standard Deviation | ml/min | 3 months |
|
|
|
|
| 26 |
| 31 |
| EG001 | Cyclosporine (CsA) | Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood. Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist. Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day. | 24 | 30 |
| Lymphocele | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Non-systematic Assessment |
|
| General malaise | General disorders | Non-systematic Assessment |
|
| Hernia | General disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | Non-systematic Assessment |
|
| Brain abscess | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Varicella | Infections and infestations | Non-systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Graft thrombosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Renal graft loss | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Transplant changes | General disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphocele | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hyperaldosteronism | Endocrine disorders | Non-systematic Assessment |
|
| Eye edema | Eye disorders | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder general | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingival hyperplasia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemorrhodial hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intra-abdominal hematoma | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric refulx | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Calcinosis | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Discomfort | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | Non-systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Fibrosis | General disorders | Non-systematic Assessment |
|
| Hernia | General disorders | Non-systematic Assessment |
|
| Impaired healing | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Necrosis | General disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Adema peripheral | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Vessel puncture site hemorrhage | General disorders | Non-systematic Assessment |
|
| Hypersenstivity | Immune system disorders | Non-systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | Non-systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Candiduria | Infections and infestations | Non-systematic Assessment |
|
| Citrobacter infection | Infections and infestations | Non-systematic Assessment |
|
| Clostridial infection | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Genital infection fungal | Infections and infestations | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Human polyomavirus | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Viral laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Transplant failure | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Non-systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tracheal obstruction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Antibody test positive | Investigations | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | Non-systematic Assessment |
|
| Blood parathyroid hormone | Investigations | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | Non-systematic Assessment |
|
| Blood urea increased | Investigations | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | Non-systematic Assessment |
|
| Cytomegalovirus test postive | Investigations | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
| Transaminases increased | Investigations | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Podagra | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| Insomina | Psychiatric disorders | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | Non-systematic Assessment |
|
| Anuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder stenosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal conjestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Obstructive airway disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertrichosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Renal surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Urethral operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Angiodysplasia | Vascular disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |