Trial · NCT02327403
Belatacept Conversion in Proteinuric Kidney Transplant Recipients
NCT02327403, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2022-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Belatacept Conversion in Proteinuric Kidney Transplant Recipients. Trials, record NCT02327403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02327403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belatacept Conversion in Proteinuric Kidney Transplant Recipients
- NCT number
- NCT02327403
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Proteinuria
- Interventions
- Belatacept
- First posted
- 2014-12-30
- Last updated
- 2022-11-09
- Results first posted
- 2022-11-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Proteinuria by 25% | 12 months | Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value. |
| Secondary | Change in Renal Function (eGFR in mL/Min/1.73 m^2) | from baseline to 12 months | |
| Secondary | Acute Rejection Episodes | 12 months | Acute rejection episodes \[Time Frame: 12 months\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months. |
| Secondary | Change in Blood Pressure Measurement (mm Hg) | 12 months | Change in Blood pressure measurement (mm Hg) \[Time Frame: 12 months\]: The mmHg difference in systolic and diastolic blood pressures between the baseline (pre-belatacept conversion) and post-conversion 12 months is assessed. Blood pressure measurement done at the office visits at baseline and 12 months after at least 5 minutes of resting. |
| Secondary | Change in Fasting Glucose | 12 months | New onset diabetes \[Time Frame: 12 months\]: Number of new onset diabetes per American Diabetes Association 2015 Criteria from belatacept conversion to post-conversion 12 months |
| Secondary | Hyperlipidemia | 12 months | Hyperlipidemia \[ Time Frame: 12 months\]: Changes (mg/dL) in serum total cholesterol, LDL, HDL, and triglyceride levels from pre-belatacept conversion to post-conversion 12 months. |
| Secondary | Graft Survival | 12 months | Graft survival \[Time Frame: 12 months\]: Number of patients who developed end stage kidney disease and required kidney replacement therapy within 12 months post-belatacept conversion. |
| Secondary | Patient Survival | 12 months |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Proteinuria by 25% | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Renal Function (eGFR in mL/Min/1.73 m^2) | from baseline to 12 months | mL/min/1.73m2 | MEAN | |
| SECONDARY | Acute Rejection Episodes | 12 months | episodes | NUMBER | |
| SECONDARY | Change in Blood Pressure Measurement (mm Hg) | 12 months | mmHg | MEAN | |
| SECONDARY | Change in Fasting Glucose | 12 months | mg/dL | MEAN | |
| SECONDARY | Hyperlipidemia | 12 months | mg/dL | MEAN | |
| SECONDARY | Graft Survival | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Survival | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Proteinuria by 25% | Belatacept Conversion | 8 | Participants | ||
| Change in Renal Function (eGFR in mL/Min/1.73 m^2) | Belatacept Conversion | Baseline | 45.8 | Standard Deviation 13.3 | mL/min/1.73m2 |
| Change in Renal Function (eGFR in mL/Min/1.73 m^2) | Belatacept Conversion | 12 Months | 45.1 | Standard Deviation 12.7 | mL/min/1.73m2 |
| Acute Rejection Episodes | Belatacept Conversion | 0 | episodes | ||
| Change in Blood Pressure Measurement (mm Hg) | Belatacept Conversion | Baseline (Systolic) | 140 | Standard Deviation 11 | mmHg |
| Change in Blood Pressure Measurement (mm Hg) | Belatacept Conversion | Baseline (Diastolic) | 76 | Standard Deviation 6 | mmHg |
| Change in Blood Pressure Measurement (mm Hg) | Belatacept Conversion | 12 Months (Systolic) | 129 | Standard Deviation 16 | mmHg |
| Change in Blood Pressure Measurement (mm Hg) | Belatacept Conversion | 12 Months (Diastolic) | 72 | Standard Deviation 9 | mmHg |
| Change in Fasting Glucose | Belatacept Conversion | Baseline | 119 | Standard Deviation 37 | mg/dL |
| Change in Fasting Glucose | Belatacept Conversion | 12 Months | 124 | Standard Deviation 62 | mg/dL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belatacept Conversion | 15 | |
| Overall Study | COMPLETED | Belatacept Conversion | 13 | |
| Overall Study | NOT COMPLETED | Belatacept Conversion | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | Pneumonia | Infections and infestations | Belatacept Conversion | 2 | 15 | 2 |
| other | Shingles | Infections and infestations | Belatacept Conversion | 1 | 15 | 1 |
| other | MRSA Cellulitis with Abscess | Infections and infestations | Belatacept Conversion | 1 | 15 | 1 |
| other | Cellulitis | Infections and infestations | Belatacept Conversion | 1 | 15 | 1 |
| other | Pyelonephritis | Infections and infestations | Belatacept Conversion | 1 | 15 | 1 |
| other | Urinary Tract Infection | Infections and infestations | Belatacept Conversion | 1 | 15 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Belatacept Conversion | 1 | 15 | 1 |
| other | Syncope | Nervous system disorders | Belatacept Conversion | 1 | 15 | 1 |
| other | Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Belatacept Conversion | 1 | 15 | 1 |
| other | Recurrence of Bladder Tumor | Renal and urinary disorders | Belatacept Conversion | 1 | 15 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belatacept Conversion | 1 | 15 |
| Total, other adverse events | Belatacept Conversion | 9 | 15 |
| Total, serious adverse events | Belatacept Conversion | 1 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02327403
GET https://conductscience.org/api/trials/v1/NCT02327403/registered