Published Studies Related to Zenapax (Daclizumab)
Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation. [2010.11]
BACKGROUND: We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. METHODS: Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C)...
Assessing renal function with daclizumab induction and delayed tacrolimus introduction in liver transplant recipients. [2010.06.27]
BACKGROUND: Calcineurin inhibitor-induced renal dysfunction is a major problem in liver transplantation. Interleukin-2 receptor antagonist induction followed by delayed tacrolimus (Tac) administration may minimize the renal insult without compromising immunoprotection... CONCLUSIONS: Delay of Tac does not benefit renal function in liver transplant recipients with a good renal function at baseline.
Daclizumab for relapsing remitting multiple sclerosis. [2010.06.16]
CONCLUSIONS: Although studies examining daclizumab for relapsing remitting multiple sclerosis were located, methodologic limitations resulted in the exclusion of all studies. Some of the studies were labelled as crossover trials, however they only compared the effect of different interventions for the same individual. The true randomized crossover trial should compare the effect of different groups, which receive the same intervention, only with the difference in sequence. In other words, the crossover comparison should be between the different groups, rather than on the individual between pretreatment and post treatment. At the same time, all the individuals should be randomly allocated to different groups. There was also a rigorous randomized controlled trial, but the follow-up was shorter than one year (only 44 weeks). In general, daclizumab is safe and well tolerated in combination of interferon treated multiple sclerosis population. Improvements in methodology in future studies are required for meaningful synthesis of data.
Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study. [2010.04.27]
BACKGROUND: In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies combined with triple immunosuppression... CONCLUSION: Basiliximab or daclizumab combined with triple therapy was an efficient and a safe immunosuppression strategy, demonstrated with low incidence of acute rejections, excellent graft function, high survival rates, and acceptable adverse event profile in adult recipients within the 1st year after deceased donor renal transplantation.
Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. [2010.04]
BACKGROUND: Daclizumab, a humanised monoclonal antibody, reduced multiple sclerosis disease activity in previous non-randomised studies. We aimed to assess whether daclizumab reduces disease activity in patients with active relapsing multiple sclerosis who are receiving interferon beta treatment... INTERPRETATION: Add-on daclizumab treatment reduced the number of new or enlarged gadolinium contrast-enhancing lesions compared with interferon beta alone and might reduce multiple sclerosis disease activity to a greater extent than interferon beta alone. FUNDING: Facet Biotech and Biogen Idec. 2010 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Zenapax (Daclizumab)
Human Anti-Tac (Daclizumab) to Treat JIA-Associated Uveitis [Completed]
This study will examine the safety and effectiveness of a monoclonal antibody called
humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with
uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis
(JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and
directed against a specific target in the body. The HAT antibody is designed to prevent a
specific chemical interaction needed for immune cells to produce inflammation. Current
treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not
always work or they may cause significant side effects. This study will determine whether
daclizumab can improve uveitis in children and reduce the need for other medicines.
Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis
requiring treatment with anti-inflammatory medications as often as three times a day or more
may be eligible for this study.
Each candidate is screened with a medical history, physical examination, blood tests, eye
examination, and the following specialized tests:
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected
into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina
are taken using a camera that flashes a blue light into the eye. The pictures show if
any dye has leaked from the vessels into the retina, indicating the presence of
- Optical coherence tomography to measure retinal thickness. The eyes are examined through
a machine that produces cross-sectional pictures of the retina. These measures are
repeated during the study to determine changes, if any, in retinal thickening.
- Stereoscopic color fundus photography to examine the back of the eye. The pupils are
dilated with eye drops to examine and photograph the back of the eye.
Upon entering the study, participants receive a 90-minute infusion of daclizumab through a
catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and
again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four
weeks after the third infusion, patients are examined for response to treatment. Those who
have benefited from daclizumab may continue receiving monthly infusions of the drug for up to
one year. A blood test and eye examination are done at the time of each infusion. Patients
whose disease has remained active 12 weeks after the first infusion are taken off the study
and treated with other medications.
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis [Active, not recruiting]
This study will examine the safety of Zenapax (daclizumab) in patients with multiple
sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes
(cells of the immune system), are thought to damage myelin, a substance that covers the nerve
and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural
substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a
genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes
with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin
that occurs in multiple sclerosis.
Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this
study. Patients with secondary-progressive or primary progressive MS may not participate.
Candidates will be screened with a complete neurological and medical evaluation and review of
Participants will undergo the following tests and procedures:
- Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over
a 3-month period to assess disease activity. For the MRI scans, the patient lies on a
table that slides into the scanner - a narrow metal cylinder with a strong magnetic
field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between
45 and 90 minutes. Only patients with activity at or above a certain level are eligible
to continue with the treatment phase of the study.
- Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax.
The first two infusions are 2 weeks apart, followed by 13 monthly infusions.
- MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease
activity and identify new brain lesions.
- Blood and urine tests: Blood and urine samples are collected at each clinic visit for
routine laboratory evaluations, immunologic study, and genetic testing to determine a
predisposition for responding to Zenapax treatment.
- Lumbar puncture (spinal tap): This procedure will be done during the last month before
starting treatment and during the seventh month of treatment to examine immune changes
that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the
brain and spinal cord. A local anesthetic is given and a needle is inserted in the space
between the bones in the lower back where the CSF circulates below the spinal cord. A
small amount of fluid is collected through the needle.
- Skin test: A needle is placed just under the skin is done to assess the patient's immune
status to common antigens such as tetanus, mumps and candida.
- Lymphocytopheresis: Lymphocytes are collected three times - once during the last month
of baseline before starting treatment, once during the fifth month of treatment, and
once during the last month of treatment - for immunologic study. Blood is collected
through a needle in an arm vein in a similar way to donating blood. The blood flows from
the vein through a catheter (plastic tube) into a machine that separates it into its
components by centrifugation (spinning). The lymphocytes are removed and the rest of the
blood (red cells, plasma and platelets) is returned to the body, either through the same
needle or through another needle in the other arm.
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma [Recruiting]
- Hodgkin's lymphoma (HL) is a highly treatable cancer. However, if HL does not respond
to chemotherapy or returns after chemotherapy, further treatments often are not
- Some HL cells have a molecule called CD25 on the surface. Daclizumab is a drug that can
detect CD25 on cells. In a treatment study for HL that did not respond to chemotherapy,
daclizumab plus a radioactive atom called Yttrium 90 helped kill these HL cells.
Researchers want to combine this 90Y daclizumab with high-dose chemotherapy and stem
cell transplant. This treatment may be more effective than the daclizumab alone.
- To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can
treat HL that has not responded to earlier treatments.
- Individuals at least 18 years of age who have Hodgkin's lymphoma that has not responded to
- Participants will be screened with a physical exam and medical history. They will also
have blood and urine tests.
- Participants will have filgrastim and plerixafor to move stem cells into the blood.
Stem cells will be collected with apheresis.
- Four weeks after stem cells are collected, participants will have the 90Y daclizumab
and normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first
- Most participants will have a second dose of 90Y daclizumab 6 weeks after the first
- After each daclizumab treatment, participants will have several imaging studies of the
chest and abdomen. Blood samples will also be collected.
- On the day after the last day of chemotherapy, participants will receive the stem cells
collected earlier. Filgrastim injections will help stimulate stem cell growth.
ANTI-TAC THERAPY FOR UVEITIS [Completed]
Uveitis refers to intraocular inflammatory diseases that are an important cause of visual
loss. Standard systemic immunosuppressive medications for uveitis can cause significant
adverse effects. Consequently, an effective treatment with a safer side effect profile is
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate
or posterior uveitis who require treatments to maintain visual function. This extended
protocol began with an evaluation of the safety and potential efficacy of intravenous (IV)
daclizumab treatments for uveitis while reducing or eliminating standard medications
commensurate with the standard of care. As subcutaneous (SC) daclizumab treatments become
available, eligible participants will be offered continuing daclizumab treatments using the
new SC formulation, though they may elect to remain on the IV treatments. If the therapeutic
benefit is sustained using the SC formulation, maintenance therapy will continue as
clinically indicated. Participants who repeatedly fail the SC therapy will be permitted to
revert to the IV daclizumab regimen they previously used, or may exit the study as treatment
failures. SC treatments begin with a short SC induction at 2 mg/kg followed by 1 mg/kg
treatments on a 4-week schedule as the protocol originally specified. Participants will be
monitored routinely when each dose is received and additionally will participate in
pharmacokinetic studies to monitor SC formulation bioavailability.
Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax) that interferes with
inflammatory processes by its involvement with the interleukin 2 receptor (IL-2R). During
the first 5 years of this study, only an IV product was available. The SC formulation is now
available containing the same daclizumab drug product. Preliminary studies indicate that the
SC formulation is well tolerated by normal control subjects and other autoimmune disease
patients at repeated doses up to 2 mg/kg.
The primary objectives are to examine the safety and potential efficacy of IV and later, SC
daclizumab, while continuing to reduce other immunosuppressive medications commensurate with
the standard of care. Primary safety outcomes are the discontinuation of study therapy due
to reduced vision or the occurrence of adverse events. Secondary outcome measures include
visual acuity and the grading of immunosuppressive medications, anterior chamber and vitreous
cells, and vitreous haze.
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk [Completed]
To compare renal allograft rejection rates during the first year among high-immunological
risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
Reports of Suspected Zenapax (Daclizumab) Side Effects
Viith Nerve Paralysis (3),
Cytomegalovirus Infection (3),
Abdominal Pain (2),
Skin Toxicity (2),
Neuropathy Peripheral (2), more >>