Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00556933 · ClinicalTrials.gov registry record · Phase 4
Improved Induction and Maintenance Immunosuppression in Kidney Transplantation
A Phase 4 study of End Stage Renal Disease, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT00556933: Completed Phase 4 study of End Stage Renal Disease, sponsored by University of Nebraska.
NCT00556933 is a Phase 4 study of End Stage Renal Disease that has completed, run by University of Nebraska. The registered enrollment target is 180 participants, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00556933, a Phase 4 study of End Stage Renal Disease, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; the other half receive the standard treatment. The two potential improvements are: 1. Administering the immunosuppression induction agent rATG ("rabbit anti-thymocyte globulin") in a single dose at the time of transplantation, instead of in the usual series of 4 smaller doses over 6 days. 2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by replacing the drug tacrolimus with mycophenolate mofetil (MMF). The two interventions, spaced sequentially six months apart, enable independent analysis of the two treatments so long as it can be shown that there is no synergistic interaction between them.
Primary Outcome
Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickeni
Conditions Studied
Interventions
- DRUG tacrolimus
- DRUG sirolimus
- DRUG mycophenolate mofetil
- DRUG rabbit anti-thymocyte globulin - single dose
- DRUG rabbit anti-thymocyte globulin - 4 doses
Study Locations (1)
Nebraska
- Unversity of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2004-04-01 |
| Est. Completion | 2011-06-01 |
| Phase | Phase 4 |
What the finished NCT00556933 record still lists
NCT00556933 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (78% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.
NCT00556933 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT00556933 about?
NCT00556933 is a clinical study titled "Improved Induction and Maintenance Immunosuppression in Kidney Transplantation". This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creat...
What is the current status of trial NCT00556933?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2004-04-01. Estimated completion is 2011-06-01.
What conditions does trial NCT00556933 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT00556933?
The interventions under investigation include: tacrolimus (DRUG), sirolimus (DRUG), mycophenolate mofetil (DRUG), rabbit anti-thymocyte globulin - single dose (DRUG), rabbit anti-thymocyte globulin - 4 doses (DRUG).
Who is sponsoring clinical trial NCT00556933?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00556933 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End Stage Renal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00556933's enrollment target sits among peer trials
180 23rd of 86 higher than 64 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ferric Citrate in ESRD Pilot Project
ACTIVE NOT RECRUITING · Phase 4
-
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
ACTIVE NOT RECRUITING · Phase 4
-
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
COMPLETED · Phase 4
-
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
COMPLETED · Phase 4
-
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
COMPLETED · Phase 4
-
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI