Trial · NCT00141037
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
NCT00141037, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2013-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation. Trials, record NCT00141037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00141037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
- NCT number
- NCT00141037
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Kidney Diseases, Kidney Transplantation, Kidney Transplant, Renal Transplantation, Renal Transplant
- Interventions
- Daclizumab, Mycophenolate mofetil (MMF), Prednisone, Tacrolimus, Ganciclovir, Valganciclovir, Trimethoprim and sulfamethoxazole
- First posted
- 2005-09-01
- Last updated
- 2016-11-29
- Results first posted
- 2013-07-11
- Limitations and caveats
1. The results cannot be generalized and daclizumab has since been withdrawn from the United States market (business-related, not due to any safety issues).~2. The study was not powered to definitively evaluate small differences in rejection rate.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | One year post kidney transplantation procedure | Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free |
| Primary | Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Up to one year post kidney transplantation procedure | Biopsy-proven acute renal (kidney) rejection \[1, 2\]. 1. Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection\[2\] 2. Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | One year post kidney transplantation procedure | All Enrolled Subjects | Standard Deviation Score (SDS) | MEAN |
| PRIMARY | Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Up to one year post kidney transplantation procedure | All Enrolled Subjects | Rejection Events | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | Steroid-Free Immunosuppression | 0.37 | Standard Deviation 0.76 | Standard Deviation Score (SDS) | |
| The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | Steroid-Based Immunosuppression | 0.35 | Standard Deviation 0.82 | Standard Deviation Score (SDS) | |
| Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Steroid-Free Immunosuppression | 18 | 95% Confidence Interval 17.85 to 43.21 | Rejection Events | |
| Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Steroid-Based Immunosuppression | 19 | 95% Confidence Interval 17.20 to 39.10 | Rejection Events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Steroid-Free Immunosuppression | 60 | |
| Overall Study | STARTED | Steroid-Based Immunosuppression | 70 | |
| Overall Study | COMPLETED | Steroid-Free Immunosuppression | 50 | |
| Overall Study | COMPLETED | Steroid-Based Immunosuppression | 52 | |
| Overall Study | NOT COMPLETED | Steroid-Free Immunosuppression | 10 | |
| Overall Study | NOT COMPLETED | Steroid-Based Immunosuppression | 18 |
Source ClinicalTrials.gov
Adverse events344
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 | Anaemia | Blood and lymphatic system disorders | Steroid-Based Immunosuppression | 21 | 70 | 21 |
| other | Anaemia | Blood and lymphatic system disorders | Steroid-Free Immunosuppression | 25 | 60 | 31 |
| other | Leukopenia | Blood and lymphatic system disorders | Steroid-Based Immunosuppression | 12 | 70 | 22 |
| other | Leukopenia | Blood and lymphatic system disorders | Steroid-Free Immunosuppression | 14 | 60 | 31 |
| other | Neutropenia | Blood and lymphatic system disorders | Steroid-Based Immunosuppression | 21 | 70 | 27 |
| other | Neutropenia | Blood and lymphatic system disorders | Steroid-Free Immunosuppression | 24 | 60 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | Steroid-Based Immunosuppression | 19 | 70 | 31 |
| other | Diarrhoea | Gastrointestinal disorders | Steroid-Free Immunosuppression | 18 | 60 | 26 |
| other | Nausea | Gastrointestinal disorders | Steroid-Based Immunosuppression | 5 | 70 | 6 |
| other | Nausea | Gastrointestinal disorders | Steroid-Free Immunosuppression | 6 | 60 | 6 |
1 to 10 of 344Source ClinicalTrials.gov
See all 344 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Steroid-Based Immunosuppression | ||
| Total, all-cause mortality | Steroid-Free Immunosuppression | ||
| Total, other adverse events | Steroid-Based Immunosuppression | 64 | 70 |
| Total, other adverse events | Steroid-Free Immunosuppression | 56 | 60 |
| Total, serious adverse events | Steroid-Based Immunosuppression | 60 | 70 |
| Total, serious adverse events | Steroid-Free Immunosuppression | 52 | 60 |
Source ClinicalTrials.gov
Papers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Steroid-Based Immunosuppression vs Steroid-Free Immunosuppression: serious adverse events |
Source 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.
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/NCT00141037
GET https://conductscience.org/api/trials/v1/NCT00141037/events?page=2