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CompletedNCT01172418Updated Sep 28, 2023Results posted

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols

A Phase 4 interventional study of Alemtuzumab and Daclizumab in Transplant; Failure, Kidney, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by University of Miami · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the present study is to determine which antibody induction regimen will result in a safer and more effective method to use with steroid avoidance in renal transplant recipients. Patients receiving either first cadaveric or non-HLA identical living donor kidney transplants will be preoperatively randomized into 2 groups.

Read the detailed description

Antibody Induction:

Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls) Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.

In both groups, Prograf® maintenance therapy will be rapidly initiated (vide-infra) with a targeting dosage to 12 hour trough levels of 4 to 8 ng/ml.

In Group I, maintenance dosing Myfortic® will be targeted to 720 mg twice daily. In Group II, maintenance doses of Myfortic® will be targeted to 360 mg twice daily.

Steroids are to be given equivalently in both groups only during the first week postoperatively. The regimen consists of 500 mg/day of Solumedrol intravenously for 3 postoperative days followed by daily oral methylprednisolone or IV Solumedrol at 1 mg/kg per day, decreasing to 0.5 mg/kg per day during the remainder of the week primarily to avoid hypersensitivity reactions to the induction antibodies. No further steroid use is planned.

02

Conditions studied

  • Transplant; Failure, Kidney

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Keywords

  • adult
  • primary kidney transplant recipient
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 200 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

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Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (12 months). Parent or legal guardian must provide written consent for patients \<18 years of age.
  2. Age 18-70 years
  3. Weight > 40 kg
  4. Primary renal allograft: living or deceased donor
  5. Negative standard crossmatch for T cells. All deceased donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center.)
  6. Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for the study duration.
  7. Males and females are to be studied equivalently as they become available for transplantation using these criteria.

Exclusion criteria

-

Exclusion Criteria:

    1. Patient has previously received or is receiving an organ transplant other than a kidney.

      1. Patient is receiving an ABO incompatible donor kidney. 3. Recipient or donor is seropositive for human immunodeficiency (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
      1. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or carcinoma in situ of the cervix that has been treated successfully.
      1. Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
      1. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
      1. Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
      1. Patient will be receiving any immunosuppressive agent other than those prescribed in the study.
      1. Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e., skin closure).
      1. Patient is receiving or may require warfarin, fluvastatin, or herbal supplements during the study.
      1. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
      1. Patient has a known hypersensitivity to tacrolimus, Thymoglobulin®, IL-2 receptor inhibitor monoclonal antibodies, alemtuzumab, sirolimus, MMF, Myfortic®, or corticosteroids.
      1. Patient is pregnant or lactating. 14. Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count \<4000/mm3; platelet count \<100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol \<30 mg/dl; fasting LDL-cholesterol >200 mg/dl.
      1. Patient is unlikely to comply with the visits scheduled in the protocol. 16. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
      1. If tacrolimus cannot be instituted for longer than 5 days postoperatively.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Thymoglobulin and Daclizumab

    Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)

    Drug: Daclizumab · Drug: Thymoglobulin

  • Experimental
    Thymoglobulin and Alemtuzumab

    Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.

    Drug: Alemtuzumab · Drug: Thymoglobulin

Interventions

  • DrugAlemtuzumab

    Alemtuzumab used as part of combined Induction.

    Also known as: Campath-1H (Alemtuzumab)

  • DrugDaclizumab

    Daclizumab used as part of combined induction.

    Also known as: Zenapax (Daclizumab)

  • DrugThymoglobulin

    Thymoglobulin used as part of combined induction.

    Also known as: rATG (rabbit antithymocyte globulin)

06

What researchers measure

Primary outcomes

  1. Incidence of Acute Rejection at One Year Post-transplant

    Time frame: at one year post-transplant

Secondary outcomes

  1. Graft Survival

    Time frame: at 1 year post-transplant

  2. Graft Survival

    Time frame: at 3 years post-transplant

  3. Patient Survival

    Time frame: at 1 year post-transplant

  4. Patient Survival

    Time frame: at 3 years post-transplant

07

Results

Posted Aug 20, 2014

Participant flow

Participant flow — Overall Study
MilestoneThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Started100100
Completed100100
Not completed00

Outcome measures

PrimaryIncidence of Acute Rejection at One Year Post-transplant
Time frame:
at one year post-transplant
Reported as:
Number · percentage of patients having BPAR
Incidence of Acute Rejection at One Year Post-transplant
percentage of patients having BPARThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Incidence of Acute Rejection at One Year Post-transplant1413
SecondaryGraft Survival
Time frame:
at 1 year post-transplant
Reported as:
Number · actuarial percentage of participants
Graft Survival
actuarial percentage of participantsThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Graft Survival92.9 (87.9 to 98.0)92.0 (86.7 to 97.3)
Statistical analysis
  • Thymoglobulin and Daclizumab vs Thymoglobulin and Alemtuzumab · Log Rank · p = 0.78
SecondaryGraft Survival
Time frame:
at 3 years post-transplant
Reported as:
Number · actuarial percentage of participants
Graft Survival
actuarial percentage of participantsThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Graft Survival90.9 (85.2 to 96.5)86.9 (80.2 to 93.5)
Statistical analysis
  • Thymoglobulin and Daclizumab vs Thymoglobulin and Alemtuzumab · Log Rank · p = 0.37
SecondaryPatient Survival
Time frame:
at 1 year post-transplant
Reported as:
Number · actuarial percentage of participants
Patient Survival
actuarial percentage of participantsThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Patient Survival96.9 (93.5 to 100.4)97 (93.6 to 100.4)
Statistical analysis
  • Thymoglobulin and Daclizumab vs Thymoglobulin and Alemtuzumab · Log Rank · p = 0.99
SecondaryPatient Survival
Time frame:
at 3 years post-transplant
Reported as:
Number · actuarial percentage of participants
Patient Survival
actuarial percentage of participantsThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Patient Survival95.9 (91.9 to 99.8)91.8 (86.4 to 97.3)
Statistical analysis
  • Thymoglobulin and Daclizumab vs Thymoglobulin and Alemtuzumab · Log Rank · p = 0.25

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Thymoglobulin and Daclizumab—29/100 (29%)8/75 (10.7%)
Thymoglobulin and Alemtuzumab—25/100 (25%)8/70 (11.4%)
Most frequent serious events
Most frequent serious events
EventThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
Patients who developed an infection that required hospitalizationInfections and infestations29/10025/100
Most frequent other events
Most frequent other events
EventThymoglobulin and DaclizumabThymoglobulin and Alemtuzumab
occurrence of NODAT in patients without pretransplant diabetesEndocrine disorders8/758/70

Baseline characteristics

Intent to treat analysis performed on all 200 patients in the trial.

Age, Continuous
Age, Continuous(participants)Thymoglobulin and DaclizumabThymoglobulin and AlemtuzumabTotal
Mean49.9 ± 1249.4 ± 1349.65 ± 12.5
Age, Categorical
Age, Categorical(Participants)Thymoglobulin and DaclizumabThymoglobulin and AlemtuzumabTotal
<=18 years000
Between 18 and 65 years9187178
>=65 years91322
Sex: Female, Male
Sex: Female, Male(Participants)Thymoglobulin and DaclizumabThymoglobulin and AlemtuzumabTotal
Female282452
Male7276148
Region of Enrollment
Region of Enrollment(participants)Thymoglobulin and DaclizumabThymoglobulin and AlemtuzumabTotal
United States100100200
08

Study locations

1 site
  • University of Miami Miller School of Medicine
    Miami, Florida 33136, United States
09

References and documents

Publications

  • Ciancio G, Gaynor JJ, Sageshima J, Guerra G, Zarak A, Roth D, Brown R, Kupin W, Chen L, Hanson L, Tueros L, Ruiz P, Livingstone AS, Burke GW 3rd. Randomized trial of dual antibody induction therapy with steroid avoidance in renal transplantation. Transplantation. 2011 Dec 27;92(12):1348-57. doi: 10.1097/TP.0b013e3182384b21. PubMed 22027927 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01172418
Lead sponsor
University of Miami
Responsible party
George W. Burke (Chief, Kidney and Kidney-Pancreas Transplantation, University of Miami) — Principal investigator
First posted
Jul 29, 2010
Start date
Feb 2006
Primary completion
May 2010
Completion
May 2010
Results posted
Aug 20, 2014
Last update
Sep 28, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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