Trial · NCT03611621
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
NCT03611621, Completed, Hansa Biopharma AB; results first posted 2025-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation. Trials, record NCT03611621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03611621
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
- NCT number
- NCT03611621
- Status
- Completed
- Enrollment
- 31 participants, actual
- Lead sponsor
- Hansa Biopharma AB
- Conditions
- Kidney Transplant Failure and Rejection
- Interventions
- Imlifidase
- First posted
- 2018-08-02
- Last updated
- 2025-02-07
- Results first posted
- 2025-02-07
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | 5 years after first dose of imlifidase (in the feeder study) | The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | 5 years after first dose of imlifidase (in the feeder study) | Overall patient survival defined as time from transplantation to death for any cause |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation. |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by analysis of plasma (P)-creatinine |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | 5 years after first dose of imlifidase (in the feeder study) | Kidney function as evaluated by proteinuria by dipstick analysis |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018). The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR): * a biopsy was taken at the time of the graft rejection episode * histological evidence of an AMR was reported in the pathology report * presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications). |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study) | Recording of comorbidities up until year 5 after treatment with imlifidase |
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5 | Recording of concomitant immunosuppressive medication |
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | 5 years after first dose of imlifidase (in the feeder study) | Blood samples were analyzed for hemoglobulin (Hb) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | 5 years after first dose of imlifidase (in the feeder study) | The primary endpoint, overall graft survival, was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored at the time of occurrence: withdrawal from the trial without graft loss, death not caused by graft loss, and end of trial without graft loss. | percentage | NUMBER |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | 5 years after first dose of imlifidase (in the feeder study) | The overall patient survival was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored: withdrawal from the trial while alive, and end of trial while alive | percentage | NUMBER |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). | 5 years after first dose of imlifidase (in the feeder study) | Patients with a visit/assessment at year 5 | mL/min/1.73m2 | MEAN |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | 5 years after first dose of imlifidase (in the feeder study) | Patients with a visit/assessment at year 5 | μmol/L | MEAN |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | 5 years after first dose of imlifidase (in the feeder study) | Patients with a visit/assessment at year 5 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Patients with a visit/assessment at year 5. Note: number of patients with suspected acute rejection episodes up until year 5. One (1) biopsy confirmed rejection episode (AMR) was reported for 1 patient approx. 9 months after transplantation. One (1) biopsy confirmed rejection episode reported in the current trial occurred in the feeder trial. Five (5) rejection episodes were not confirmed by biopsy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | 5 years after first dose of imlifidase (in the feeder study) | Patients with a visit/assessment at year 5. Any medication (e.g. Intravenous immunoglobulin \[IVIg\]) given for graft rejection episodes | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study) | All patients with a comorbidity reported. Note: any single patient could have more than one comorbidity reported. | participants with comorbidity | NUMBER |
| SECONDARY | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. | 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5 | Immunosuppressive medications were recorded for 30 of the 31 patients enrolled | participants | NUMBER |
| SECONDARY | Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | 5 years after first dose of imlifidase (in the feeder study) | All patients with a visit/assessment at year 5 | g/L | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | Imlifidase | 91 | 95% Confidence Interval 75 to 97 | percentage | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | Imlifidase | 92 | 95% Confidence Interval 77 to 97 | percentage | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). | Imlifidase | 50.74 | Standard Deviation 19.38 | mL/min/1.73m2 | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | Imlifidase | 141.3 | Standard Deviation 69.9 | μmol/L | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | Imlifidase | Positive | 14 | Participants | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | Imlifidase | Negative | 13 | Participants | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | Imlifidase | Not done | 3 | Participants | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | Imlifidase | 0 suspected acute rejection episodes | 23 | Participants | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | Imlifidase | 1 suspected acute rejection episode | 7 | Participants | |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | Imlifidase | 2 | Participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imlifidase | 37 | |
| Overall Study | COMPLETED | Imlifidase | 30 | |
| Overall Study | NOT COMPLETED | Imlifidase | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imlifidase | 0 | 31 |
| Total, other adverse events | Imlifidase | 0 | 31 |
| Total, serious adverse events | Imlifidase | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41394519 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT03611621
GET https://conductscience.org/api/trials/v1/NCT03611621/results?page=2