End Stage Renal DiseaseNCT00586716

Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

A study testing intravenous immune globulin in people with End Stage Renal Disease, run by Loma Linda University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 12 to 80 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: intravenous immune globulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: No sites listed yet
Study dates: Nov 2004to Oct 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

12 years of age or older
diagnosed with end stage renal disease
currently receiving either hemodialysis or peritoneal dialysis
active on the kidney or kidney/pancreas transplant list
medical clearance of the kidney donor if live related transplant
elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

Who cannot join

received IVIG within 6 months prior to enrollment
HIV positive
Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
Selective IgA deficiency or known antibodies to IgA
Allergy to human immune globulin
Pregnant or breast feeding

About this study

Official title: IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA

Read the detailed description

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Conditions: End Stage Renal Disease
Being tested: intravenous immune globulin
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intravenous immune globulinDrug
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Study groups in NCT00586716
Study group	Role	What they receive
Group 1 intravenous immune globulin	Other	Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list Receives: Drug: intravenous immune globulin
Group 2 intravenous immune globulin	Other	Intravenous immune globulin for patients who have living donors with positive crossmatch results. Receives: Drug: intravenous immune globulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Elimination of Donor Specific Antibodies
Measured: 1 year

Secondary outcomes (1)

Negative B and T Cell Crossmatch
Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Oct 2009

First posted4 Jan 2008 (estimated)
Study startNov 2004
Primary completionSep 2009
Study completionOct 2009

Why it stopped: Insufficient recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00586716
Sponsor's protocol ID: 54298
Status last verified: Apr 2016
First submitted: 21 Dec 2007
Last updated: 9 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA
ClinicalTrials.gov ID: NCT00586716
Acronym / sponsor ID: 54298
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient recruitment
Enrolment: 22 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: Nov 2004
Primary completion: Sep 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 4 Jan 2008 (estimated)
Results: Posted 6 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 intravenous immune globulin	Other	Drug: intravenous immune globulinIntravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
Group 2 intravenous immune globulin	Other	Drug: intravenous immune globulinIntravenous immune globulin for patients who have living donors with positive crossmatch results.

Who may qualify

Ages: 12 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

12 years of age or older
diagnosed with end stage renal disease
currently receiving either hemodialysis or peritoneal dialysis
active on the kidney or kidney/pancreas transplant list
medical clearance of the kidney donor if live related transplant

Key exclusion criteria (6 listed)

received IVIG within 6 months prior to enrollment
HIV positive
Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
Selective IgA deficiency or known antibodies to IgA
Allergy to human immune globulin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intravenous immune globulin0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments	Drug	Group 1 intravenous immune globulin, Group 2 intravenous immune globulin

Primary outcome

Elimination of Donor Specific Antibodies
Time frame: 1 year

1 secondary outcome

Negative B and T Cell Crossmatch
Time frame: 1year

Results and safety

Results posted to the registry on 6 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Intravenous Immune Globulin no Living Donor	14	14
Group 2 Intravenous Immune Globulin With Living Donor	8	8

Primary outcome: Elimination of Donor Specific Antibodies

Time frame: 1 year

Population analysed: Study was terminated and no data for the outcome was collected/analyzed because it could not be located.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Intravenous Immune Globulin	0 of 0	0 of 0	Not reported
Group 2 Intravenous Immune Globulin	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): A limitation to this study is early termination leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Okechukwu Ojogho, MD principal investigator

Loma Linda Universtiy Adventist Health Sciences Center

Questions about this trial

What is this clinical trial studying?

A study testing intravenous immune globulin in people with End Stage Renal Disease, run by Loma Linda University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elimination of Donor Specific Antibodies (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00586716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.