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| ID | Type | Description | Link |
|---|---|---|---|
| IND15806 | Other Identifier | FDA |
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The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high risk for delayed graft function (DGF) may show significant improvement in outcomes post transplant compared with patients that do not receive C1INH treatment. Complement activation has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI) and inflammatory cell infiltrates. By blocking complement activation the investigators hope to improve kidney graft function post transplant in these recipients.
Early graft function has a long-term effect on graft survival. Poor early graft function and delayed graft function (DGF) contributes to decreased short- and long-term patient and graft survival, increased incidence of acute rejection, prolonged hospitalization, and higher costs of transplantation. Although multiple factors contribute to the impaired graft function, ischemia-reperfusion injury (IRI) is the underlying pathophysiology leading to poor early graft function and DGF. A >35% incidence of DGF has remained constant over time despite significant improvements in immunosuppressive strategies and patient management. This may be due to increased use of kidneys from "extended-criteria" and/or non-heart-beating donors, where even greater rates (>60%) of DGF have been reported.
More than 96,680 people are currently waiting for a kidney transplant in the United States (United Network for Organ Sharing (UNOS); UNOS.org 3/22/13). Of the 15,092 kidney transplants performed in the US in 2011, ~11,000 (62%) were from deceased donors. Of these, approximately 17% were from expanded-criteria donors. The USRDS reports that more than 50% of patients on the waiting list are willing to accept a kidney from an expanded-criteria donor (ECD) or donors after cardiac death (DCD).
From the investigators previous studies with C1INH (Berinert®) for prevention of antibody mediated rejection (ABMR), the investigators noted that no patients developed ABMR during treatment with C1INH, the investigators also noted a near significant reduction in DGF due to IRI (ClinicalTrials.gov(NCT01134510), FDA Investigational New Drug (IND#): 14363). These findings suggest an important role for complement in the mediation of IRI and that inhibition of early complement activation using C1INH in patients receiving at risk kidneys for IRI should reduce this costly and often devastating complication of kidney transplantation. In addition, numerous other studies in animal models have shown dramatic improvements in IRI models with the use of C1INH. Complement activation is detectable in animal and in human kidneys models after IRI and experimental data suggests that use of C1INH prior to induction of IRI significantly reduces IRI as well as inflammatory cell infiltrates. Based on this, the investigators hypothesize that the use of C1INH in patients receiving deceased donor (DD) kidney transplants with high risk for DGF will show significant reductions in DGF and improved outcomes post-transplant compared with patients receiving DD transplants who do not receive C1INH treatment. Here, the investigators propose to investigate the application of pre-operative and post-transplant doses of C1INH (Berinert®) vs. placebo in adult subjects receiving a DD renal allograft considered at high-risk for IRI and DGF. The investigators hypothesize that C1INH treated patients will demonstrate improved function of the kidney allograft compared to placebo, with equivalence in safety. The primary objectives of this study are: Using a double blinded, placebo controlled format, the investigators will:
1. Evaluate and compare the safety of C1INH (50 units/kilogram, round to the nearest 500 unit) administered pre-transplant and 24 hrs post-transplant in recipients of kidney allografts from high risk for IRI deceased donors.
The secondary objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C1-Inhibitor (Berinert) (Human) (C1INH) | Experimental | 35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy. |
|
| Normal Saline | Placebo Comparator | 35 patients will receive placebo in addition to standard of care immunosuppressive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1 Esterase Inhibitor | Drug | C1 Esterase Inhibitor 50 units per kilogram intravenous infusion administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5 | First 7 days post-transplant |
| Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia). | First 7 days post-transplant |
| Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant. | First 7 days post-transplant |
| Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | Mean quantity of dialysis sessions per patient in the first 7 days post transplant. | First 7 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine | Mean serum creatinine on day 90 in mg/dL | Up to 90 days post-transplant |
| Creatinine Clearance | Creatinine clearance calculated based on serum creatinine, milliliters per minute. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Incidence of Serious Adverse Events | Overall incidence of serious adverse events in the C1INH and placebo groups, number of events. | Up to 9 months post-transplant |
| Patient Survival | Patient survival at 90 days post-transplantation |
Inclusion Criteria:
Risk index (minimum 3- maximum 8):
DGF scale: Donor Age (<40yr = 0, 41-49yr = 1, 50-54yr = 2, 55-59yr = 3, >60yr=6), Cold Ischemia Time (0-12= 0, 13-18=1, 19-24=2, 24-30=3, 31-36=4, >37=6; Recipient Race (nonblack = 0, black =1); Donor death due to Cerebrovascular Accident (CVA) (donor age <50yrs = 0, donor age >50yrs = 3).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley C Jordan, MD | Cedars-Sinai Medical Center, Los Angeles, CA | Principal Investigator |
| Ashley Vo, PharmD | Cedars-Sinai Medical Center, Los Angeles, CA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22683724 | Background | Dalle Lucca JJ, Li Y, Simovic M, Pusateri AE, Falabella M, Dubick MA, Tsokos GC. Effects of C1 inhibitor on tissue damage in a porcine model of controlled hemorrhage. Shock. 2012 Jul;38(1):82-91. doi: 10.1097/SHK.0b013e31825a3522. | |
| 18725015 | Background | Pascual J, Zamora J, Pirsch JD. A systematic review of kidney transplantation from expanded criteria donors. Am J Kidney Dis. 2008 Sep;52(3):553-86. doi: 10.1053/j.ajkd.2008.06.005. |
| Label | URL |
|---|---|
| Cedars Sinai Medical Center Kidney Transplantation | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | C1-Inhibitor (Berinert) (Human) (C1INH) | 35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy. C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses |
| FG001 | Normal Saline | 35 patients will receive placebo in addition to standard of care immunosuppressive therapy. Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C1-Inhibitor (Berinert) (Human) (C1INH) | 35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy. C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses |
| BG001 |
| 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 | Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5 | Posted | Count of Participants | Participants | First 7 days post-transplant |
|
Adverse event data collected up to 9 months post transplant.
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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 | C1-Inhibitor (Berinert) (Human) (C1INH) | 35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy. C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Generalized fatigue described by the patient |
The limitations of this study include the small sample size and single-center performance. However, the patient population was balanced between the two groups and donor organ characteristics, including implantation biopsies, were similar.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noriko Ammerman, PharmD | Cedars-Sinai Medical Center | 310-248-8186 | noriko.ammerman@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2014 | Mar 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| D051799 | Delayed Graft Function |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
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|
| Placebo | Drug | Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses |
|
|
| Up to 90 days post-transplant |
| 24h Urine Output | 24 hour urine output post-transplantation measured in milliliters | 24 hours post-transplant |
| Mean Number of Patients on Dialysis | Mean number of patients on dialysis at 15 to 30 days post-transplant | 15 to 30 days post-transplantation |
| Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | DGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation >70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of >70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation <70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of <70% with need for dialysis. | First 7 days post-transplant |
| Up to 90 days post-transplant |
| Rate of Acute Cellular Rejection (ACR) | Number of acute cellular and antibody mediated rejection episodes by day 90. | Up to 90 days post-transplant |
| Graft Survival | Number of Participants with Graft Survival at 90 Days Post-Transplant | Day 90 Post-transplant |
| 20150432 | Background | Castellano G, Melchiorre R, Loverre A, Ditonno P, Montinaro V, Rossini M, Divella C, Battaglia M, Lucarelli G, Annunziata G, Palazzo S, Selvaggi FP, Staffieri F, Crovace A, Daha MR, Mannesse M, van Wetering S, Paolo Schena F, Grandaliano G. Therapeutic targeting of classical and lectin pathways of complement protects from ischemia-reperfusion-induced renal damage. Am J Pathol. 2010 Apr;176(4):1648-59. doi: 10.2353/ajpath.2010.090276. Epub 2010 Feb 11. |
| 9734625 | Background | Giral-Classe M, Hourmant M, Cantarovich D, Dantal J, Blancho G, Daguin P, Ancelet D, Soulillou JP. Delayed graft function of more than six days strongly decreases long-term survival of transplanted kidneys. Kidney Int. 1998 Sep;54(3):972-8. doi: 10.1046/j.1523-1755.1998.00071.x. |
| Information of C1INH (Berinert) | View source |
| Normal Saline |
35 patients will receive placebo in addition to standard of care immunosuppressive therapy. Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Patients were categorized as either African American or not African American. | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Donor Age | Mean | Standard Deviation | years |
|
| Donor Creatinine | Mean | Standard Deviation | mg/dL |
|
| Donor DCD Cause of Death | The kidney transplant donor was a Donor after Cardiac Death (DCD). | Count of Participants | Participants |
|
| Donor KDPI | Mean kidney transplant donor Kidney Donor Profile Index (KDPI), shown as a percentage. Kidneys with a high KDPI are associated with higher rates of DGF and worse long term survival in comparison to those with a low KDPI. In this study, the eligibility criteria included recipients of kidney allografts from ECD (or KDPI >/= 85) donors. A KDPI >/= 85 confers the highest risk for DGF and allograft loss. | Mean | Standard Deviation | % |
|
| Donor KDPI equal to or greater than 85% | The donor's Kidney Donor Profile Index (KDPI) was equal to or greater than 85%. Mean kidney transplant donor Kidney Donor Profile Index (KDPI), shown as a percentage. Kidneys with a high KDPI are associated with higher rates of DGF and worse long term survival in comparison to those with a low KDPI. In this study, the eligibility criteria included recipients of kidney allografts from ECD (or KDPI >/= 85) donors. A KDPI >/= 85 confers the highest risk for DGF and allograft loss. | Count of Participants | Participants |
|
| Transplant Cold Ischemia Time | Mean | Standard Deviation | hours |
|
| Anti-HLA DSA | Anti-Human leukocyte antigen (HLA) Donor Specific Antibody (DSA) | Count of Participants | Participants |
|
| HLA Class I Antibodies Present | Human leukocyte antigen (HLA) Class I Antibodies | Count of Participants | Participants |
|
| HLA Class II Antibodies Present | Human leukocyte antigen (HLA) Class II Antibodies | Count of Participants | Participants |
|
| Treatment with Thymoglobulin at transplantation | Patients who received thymoglobulin as an induction agent at transplant | Count of Participants | Participants |
|
| Treatment with Alemtuzumab at transplantation | Patients who received alemtuzumab (Campath) as an induction agent at transplant | Count of Participants | Participants |
|
|
|
| Primary | Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia). | Posted | Count of Participants | Participants | First 7 days post-transplant |
|
|
|
| Primary | Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant. | Posted | Count of Participants | Participants | First 7 days post-transplant |
|
|
|
| Primary | Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | Mean quantity of dialysis sessions per patient in the first 7 days post transplant. | Posted | Mean | Standard Deviation | dialysis sessions | First 7 days post-transplant |
|
|
|
| Secondary | Serum Creatinine | Mean serum creatinine on day 90 in mg/dL | Posted | Mean | Standard Deviation | mg/dL | Up to 90 days post-transplant |
|
|
|
| Secondary | Creatinine Clearance | Creatinine clearance calculated based on serum creatinine, milliliters per minute. | Posted | Mean | Standard Deviation | ml/minute | Up to 90 days post-transplant |
|
|
|
| Secondary | 24h Urine Output | 24 hour urine output post-transplantation measured in milliliters | Posted | Mean | Standard Deviation | milliliters | 24 hours post-transplant |
|
|
|
| Secondary | Mean Number of Patients on Dialysis | Mean number of patients on dialysis at 15 to 30 days post-transplant | Posted | Count of Participants | Participants | 15 to 30 days post-transplantation |
|
|
|
| Secondary | Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | DGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation >70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of >70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation <70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of <70% with need for dialysis. | Posted | Count of Participants | Participants | First 7 days post-transplant |
|
|
|
| Other Pre-specified | Overall Incidence of Serious Adverse Events | Overall incidence of serious adverse events in the C1INH and placebo groups, number of events. | Posted | Number | events | Up to 9 months post-transplant |
|
|
|
| Other Pre-specified | Patient Survival | Patient survival at 90 days post-transplantation | Posted | Count of Participants | Participants | Up to 90 days post-transplant |
|
|
|
| Other Pre-specified | Rate of Acute Cellular Rejection (ACR) | Number of acute cellular and antibody mediated rejection episodes by day 90. | Posted | Number | episodes | Up to 90 days post-transplant |
|
|
|
| Other Pre-specified | Graft Survival | Number of Participants with Graft Survival at 90 Days Post-Transplant | Posted | Count of Participants | Participants | Day 90 Post-transplant |
|
|
|
| 0 |
| 35 |
| 10 |
| 35 |
| 28 |
| 35 |
| EG001 | Normal Saline | 35 patients will receive placebo in addition to standard of care immunosuppressive therapy. Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses | 0 | 35 | 10 | 35 | 26 | 35 |
| Neutropenia/Fever | Infections and infestations | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Purulent Drainage from wound | Infections and infestations | Systematic Assessment |
|
| Acute Encephalopathy | Infections and infestations | Systematic Assessment |
|
| Sepsis from Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Diabetic Ketoacidosis | Endocrine disorders | Systematic Assessment |
|
| Flash pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| A fib, shortness of breath, chest pain | Cardiac disorders | Systematic Assessment |
|
| Right leg DVT | Cardiac disorders | Systematic Assessment |
|
| Upper extermity/facial swelling, SVC syndrome | Cardiac disorders | Systematic Assessment |
|
| A flutter | Cardiac disorders | Systematic Assessment |
|
| Afib/ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Non ST segment elevation | Cardiac disorders | Systematic Assessment |
|
| Elevated creatinine/edema | Renal and urinary disorders | Systematic Assessment |
|
| Nephrectomy due to poor perfusion | Renal and urinary disorders | Systematic Assessment |
|
| Urine Leak | Renal and urinary disorders | Systematic Assessment |
|
| Peri-renal transplant hematoma | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Slurred speech/weakness/fatigue | Nervous system disorders | Systematic Assessment |
|
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Edema | Cardiac disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Shortness of Breath | Cardiac disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015843 |
| Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |