Trial · NCT01729494

Belatacept Early Steroid Withdrawal Trial

NCT01729494, Phase 4, Completed, University of Cincinnati; results first posted 2021-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Belatacept Early Steroid Withdrawal Trial. Trials, record NCT01729494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01729494

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Belatacept Early Steroid Withdrawal Trial
NCT number: NCT01729494
Status: Completed
Phases: Phase 4
Enrollment: 316 participants, actual
Lead sponsor: University of Cincinnati
Conditions: Renal Transplantation
Interventions: Alemtuzumab, rabbit antithymocyte globulin, Belatacept, Tacrolimus, Mycophenolate mofetil, early cessation of steroids
First posted: 2012-11-20
Last updated: 2026-07-24
Results first posted: 2021-07-28

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min	12 months	Number of Patients who experienced any of the following including patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) \< 45 mL/min
Secondary	Number of Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)	24 months	Number of patients who experienced Graft loss, not including (censored) patients who lost graft due to death
Secondary	Number of Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months	24 months	Composite Endpoint of number of patients who experienced either patient death, allograft loss, or had an eGFR \< 45 ml/min/1.73m2
Secondary	eGFR (MRDRD) < 45 ml/Min/1.73m2	24 months	Patients with reduced Renal function measured by estimated GFR MDRD \< 45 ml/min at 24 months
Secondary	Biopsy Proven Acute Rejection	24 months	Incidence of all biopsy proven acute rejection whether clinically relevant or clinically silent.
Secondary	Biopsy Proven Acute Cellular Rejection	24 months	Biopsy proven acute cellular rejection (BPACR)
Secondary	Biopsy Proven Acute Antibody Mediated Rejection	24 months	Incidence of patients experiencing a Biopsy proven acute antibody mediated rejection (BPAMR)
Secondary	Biopsy Proven Mixed Acute Rejection	24 months	Incidence of patients experiencing a Biopsy proven acute cellular rejection with either DSA positive or C4d staining positive indicating antibody rejection
Secondary	Number of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant	24 months	Number of patients (%) with development of denovo DSA after transplant
Secondary	Mean eGFR (MDRD) (ml/Min/1.73m2)	24 months	Mean eGFR (MDRD) (ml/min/1.73m2) measured for all patients reaching 2 year endpoint

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min	12 months	Intent to treat analysis	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)	24 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	eGFR (MRDRD) < 45 ml/Min/1.73m2	24 months	Intent to Treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biopsy Proven Acute Rejection	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biopsy Proven Acute Cellular Rejection	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biopsy Proven Acute Antibody Mediated Rejection	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biopsy Proven Mixed Acute Rejection	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	# of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant	24 months	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean eGFR (MDRD) (ml/Min/1.73m2)	24 months	Intent to treat	ml/min/1.73m2	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group63

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min	Group A	9	Participants
# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min	Group B	15	Participants
# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min	Group C	14	Participants
# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)	Group A	0	Participants
# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)	Group B	1	Participants
# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)	Group C	1	Participants
# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months	Group A	11	Participants
# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months	Group B	13	Participants
# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months	Group C	21	Participants
eGFR (MRDRD) < 45 ml/Min/1.73m2	Group A	9	Participants

1 to 10 of 63Source ClinicalTrials.gov

See all 63 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group A	107
Overall Study	STARTED	Group B	104
Overall Study	STARTED	Group C	105
Overall Study	COMPLETED	Group A	97
Overall Study	COMPLETED	Group B	93
Overall Study	COMPLETED	Group C	94
Overall Study	NOT COMPLETED	Group A	10
Overall Study	NOT COMPLETED	Group B	11
Overall Study	NOT COMPLETED	Group C	11

Source ClinicalTrials.gov

Adverse events51

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
other	Hematologic events	Blood and lymphatic system disorders	Group A	59	107
other	Hematologic events	Blood and lymphatic system disorders	Group B	55	104
other	Hematologic events	Blood and lymphatic system disorders	Group C	60	105
other	Leukopenia WBC < 2000/mm3	Blood and lymphatic system disorders	Group A	22	107
other	Leukopenia WBC < 2000/mm3	Blood and lymphatic system disorders	Group B	14	104
other	Leukopenia WBC < 2000/mm3	Blood and lymphatic system disorders	Group C	15	105
other	Anemia (Hg < 7gm/dL)	Blood and lymphatic system disorders	Group A	2	107
other	Anemia (Hg < 7gm/dL)	Blood and lymphatic system disorders	Group B	3	104
other	Anemia (Hg < 7gm/dL)	Blood and lymphatic system disorders	Group C	6	105
other	Thrombocytopenia (PLT < 50,000/mm3)	Blood and lymphatic system disorders	Group A	5	107

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group A	2	107
Total, all-cause mortality	Group B	4	104
Total, all-cause mortality	Group C	1	105
Total, other adverse events	Group A	91	107
Total, other adverse events	Group B	90	104
Total, other adverse events	Group C	92	105
Total, serious adverse events	Group A	58	107
Total, serious adverse events	Group B	66	104
Total, serious adverse events	Group C	62	105

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31415033	DERIVED	PubMed
34233921	DERIVED	PubMed
40704545	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01729494

GET https://conductscience.org/api/trials/v1/NCT01729494/registered?page=2

API reference For AI assistants