Trial · NCT02134314
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
NCT02134314, Phase 1, Phase 2, Completed, Cedars-Sinai Medical Center; results first posted 2018-06-25
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI. Trials, record NCT02134314. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02134314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
- NCT number
- NCT02134314
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- End Stage Renal Disease, Kidney Failure, Delayed Graft Function, Ischemic Reperfusion Injury
- Interventions
- C1 Esterase Inhibitor, Placebo
- First posted
- 2014-05-09
- Last updated
- 2018-06-25
- Results first posted
- 2018-06-25
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | First 7 days post-transplant | Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5 |
| Primary | Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | 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). |
| Primary | Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | First 7 days post-transplant | Number of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant. |
| Primary | Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | First 7 days post-transplant | Mean quantity of dialysis sessions per patient in the first 7 days post transplant. |
| Secondary | Serum Creatinine | Up to 90 days post-transplant | Mean serum creatinine on day 90 in mg/dL |
| Secondary | Creatinine Clearance | Up to 90 days post-transplant | Creatinine clearance calculated based on serum creatinine, milliliters per minute. |
| Secondary | 24h Urine Output | 24 hours post-transplant | 24 hour urine output post-transplantation measured in milliliters |
| Secondary | Mean Number of Patients on Dialysis | 15 to 30 days post-transplantation | Mean number of patients on dialysis at 15 to 30 days post-transplant |
| Secondary | Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | First 7 days post-transplant | 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. |
| Other | Overall Incidence of Serious Adverse Events | Up to 9 months post-transplant | Overall incidence of serious adverse events in the C1INH and placebo groups, number of events. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | First 7 days post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | First 7 days post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | First 7 days post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | First 7 days post-transplant | dialysis sessions | MEAN | |
| SECONDARY | Serum Creatinine | Up to 90 days post-transplant | mg/dL | MEAN | |
| SECONDARY | Creatinine Clearance | Up to 90 days post-transplant | ml/minute | MEAN | |
| SECONDARY | 24h Urine Output | 24 hours post-transplant | milliliters | MEAN | |
| SECONDARY | Mean Number of Patients on Dialysis | 15 to 30 days post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | First 7 days post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Overall Incidence of Serious Adverse Events | Up to 9 months post-transplant | events | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | C1-Inhibitor (Berinert) (Human) (C1INH) | 29 | Participants | ||
| Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | Normal Saline | 32 | Participants | ||
| Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | C1-Inhibitor (Berinert) (Human) (C1INH) | 15 | Participants | ||
| Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | Normal Saline | 21 | Participants | ||
| Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | C1-Inhibitor (Berinert) (Human) (C1INH) | 30 | Participants | ||
| Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | Normal Saline | 28 | Participants | ||
| Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | C1-Inhibitor (Berinert) (Human) (C1INH) | 0.97 | Standard Deviation 1.22 | dialysis sessions | |
| Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. | Normal Saline | 1.54 | Standard Deviation 1.54 | dialysis sessions | |
| Serum Creatinine | C1-Inhibitor (Berinert) (Human) (C1INH) | 1.3 | Standard Deviation 0.317 | mg/dL | |
| Serum Creatinine | Normal Saline | 1.7 | Standard Deviation 1.410 | mg/dL |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | C1-Inhibitor (Berinert) (Human) (C1INH) | 35 | |
| Overall Study | STARTED | Normal Saline | 35 | |
| Overall Study | COMPLETED | C1-Inhibitor (Berinert) (Human) (C1INH) | 34 | |
| Overall Study | COMPLETED | Normal Saline | 34 | |
| Overall Study | NOT COMPLETED | C1-Inhibitor (Berinert) (Human) (C1INH) | 1 | |
| Overall Study | NOT COMPLETED | Normal Saline | 1 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | C1-Inhibitor (Berinert) (Human) (C1INH) | 2 | 35 | 2 |
| other | Fatigue | General disorders | Normal Saline | 5 | 35 | 5 |
| other | Hyperglycemia | Endocrine disorders | C1-Inhibitor (Berinert) (Human) (C1INH) | 2 | 35 | 2 |
| other | Hyperglycemia | Endocrine disorders | Normal Saline | 0 | 35 | 0 |
| other | Constipation | Gastrointestinal disorders | C1-Inhibitor (Berinert) (Human) (C1INH) | 3 | 35 | 3 |
| other | Constipation | Gastrointestinal disorders | Normal Saline | 3 | 35 | 3 |
| other | Hyperkalemia | Metabolism and nutrition disorders | C1-Inhibitor (Berinert) (Human) (C1INH) | 7 | 35 | 7 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Normal Saline | 7 | 35 | 7 |
| other | Hypertension | Cardiac disorders | C1-Inhibitor (Berinert) (Human) (C1INH) | 1 | 35 | 1 |
| other | Hypertension | Cardiac disorders | Normal Saline | 7 | 35 | 7 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C1-Inhibitor (Berinert) (Human) (C1INH) | 0 | 35 |
| Total, all-cause mortality | Normal Saline | 0 | 35 |
| Total, other adverse events | C1-Inhibitor (Berinert) (Human) (C1INH) | 28 | 35 |
| Total, other adverse events | Normal Saline | 26 | 35 |
| Total, serious adverse events | C1-Inhibitor (Berinert) (Human) (C1INH) | 10 | 35 |
| Total, serious adverse events | Normal Saline | 10 | 35 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Mean Number of Patients on Dialysis | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale) | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Graft Survival | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Patient Survival | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: deaths from any cause | Trial comparisons |
| C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02134314
GET https://conductscience.org/api/trials/v1/NCT02134314/results?page=2