Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01280617
Other study ID # 2010-065
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2010
Est. completion date January 2014

Study information

Verified date February 2021
Source Lahey Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.


Description:

Detailed Study Design: This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant. The investigators will obtain the following information at the time of consent: 1. Type of renal transplant (living vs cadaveric) 2. HLA matching 3. CMV status of donor and recipient 4. EBV status of donor and recipient 5. Creatinine prior to transplantation 6. Urinalysis at the time of transplantation 7. Primary renal disease 8. Weight of the renal transplant 9. BMI of the recipient and donor 10. Age of the donor and recipient 11. Sex of the donor and recipient 12. White blood cell count 13. Hemoglobin 14. Platelets 15. History of infections 16. History of malignancies During each of the clinic visits the investigators will obtain the following information: 1. Creatinine 2. Urinalysis 3. White blood cell count 4. Hemoglobin 5. Platelets 6. Weight of the recipient 7. Infections 8. Malignancies 9. Renal biopsy report if a biopsy was performed In addition to the standard of care laboratories, the investigators will ask patients to give us 7 additional green tubes, one purple tube and two red tubes which will be drawn at the time of standard of care laboratories pre-transplantation, 3 months post-transplant, 6 months post-transplant and 12 months post-transplant. This tubes will be used to measure CD4, CD8, CD19, CD20, CD68 cells as these are cells that are believed to be affected by the use of thymoglobulin. If the patient is to have a renal transplant biopsy at any time during the 12 months of the study, any excess tissue may be utilized for staining of special cell markers including CD4, CD8, CD19, CD20 and CD68. Subject inclusion criteria: Potential adult renal transplant recipients Subject exclusion criteria: Sensitized renal transplant recipients Methods of statistical analysis to be employed in preparation of reports: The investigators are planning a study with 1 control per experimental subject, an accrual interval of 24 time units, and additional follow-up after the accrual interval of 12 time units. In a previous study the median survival time on the control treatment was 36 time units. If the true hazard ratio (relative risk) of control subjects relative to experimental subjects is 5, the investigators will need to study 43 experimental subjects and 43 control subjects to be able to reject the null hypothesis that the experimental and control survival curves are equal with probability (power) .800. The Type I error probability associated with this test of this null hypothesis is 0.05. T-tests will be used to compare both groups. Thymoglobulin (rabbit antithymocyte globulin) is FDA approved for the treatment of acute cellular rejection. Nevertheless, for at least the past 10 years this medication has been utilized as induction agent in renal transplant recipients. This is because an induction agent allows prednisone withdrawal in renal transplant recipients. Prednisone withdrawal is extremely important in renal transplant recipients as old protocols that allowed long term prednisone use compromised the long term health of renal transplant recipients. Not only does prednisone increase markedly the risk of development of diabetes and osteoporosis, but is also increases drastically the risk of fractures, which is a very common cause of mortality in long term prednisone renal transplant recipients.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Potential Adult Renal Transplant Patients - Exclusion Criteria: Sensitized Renal Transplant Patients -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Thymoglobulin
Thymoglobulin 1.25mg/kg dose
Thymoglobulin 0.75mg/kg dose
Thymoglobulin

Locations

Country Name City State
United States Lahey Clinic Burlington Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Lahey Clinic Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of Acute Cellular Rejection Between Study Group Incidence of Biopsy Proven Acute Rejection at 1 year post transplant: 1 year from date of transplant
Secondary , "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy" Number of individual adverse events in high versus low dose Thymoglobulin groups will be tabulated and statistical analyses performed 1 year from date of transplant
See also
  Status Clinical Trial Phase
Completed NCT01946113 - Mineral-Homeostasis in Continuous Renal Replacement Therapy N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Withdrawn NCT00993733 - Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care N/A
Terminated NCT00978354 - Furosemide in Early Acute Kidney Injury Phase 2/Phase 3
Completed NCT00120263 - Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma N/A
Completed NCT04799600 - The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
Recruiting NCT04334707 - Kidney Precision Medicine Project
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Recruiting NCT05282732 - Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Completed NCT01467466 - Prevention of Serious Adverse Events Following Angiography Phase 3
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT00780351 - Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f) N/A
Completed NCT00971971 - Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients N/A
Completed NCT00076219 - Acute Renal Failure Trial Network (ATN) Study Phase 3
Recruiting NCT04599569 - Influence of Renal Replacement TherApy on Indirect Calorimetry
Completed NCT03727204 - Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Completed NCT06005896 - A Clinical Model for Dialysis Discontinuation in AKI
Completed NCT03004950 - Biomarker Effectiveness Analysis in Contrast Nephropathy (BEACON)
Completed NCT03627884 - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation Phase 4
Recruiting NCT04682236 - Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation