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immunoglobulins

Phase 1

Renal Failure, Chronic | Small molecule | Nephrology |Roche Holding AG|Last Updated: May 10, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

immunoglobulins · 1 trial · 2 indications

Early Phase 1 1
NCT00176059Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant RecipientsRenal Failure, Chronic
COMPLETED50 Analytics
EARLY_PHASE1COMPLETED
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
Renal Failure, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

patient survival
1 year / 3 years / 5 years posttransplant
graft survival
1 year / 3 years / 5 years posttransplant
acute rejection
1 year
chronic allograft nephropathy
3 years / 5 years posttransplant

Secondary Endpoints

graft function
1 year / 3 years / 5 years
infectious complications
1 year
immunoglobulin levels
1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
intravenous immunoglobulins (IVIG)DRUG -
kidney transplantationPROCEDURE -
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Eligibility Criteria

Age Range14 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * renal transplant recipients of the Giessen renal transplant unit * cadaveric and living renal transplants * first and retransplants Exclusion Criteria: * Contraindications against blood-taking (anaemia with hemoglobin \< 9,5 g/l, hypotension) * intravenous immunoglobulin the...

Countries:Germany
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Frequently asked questions about immunoglobulins

What is immunoglobulins used for in renal failure?

Immunoglobulins is an investigational small molecule being studied for use in chronic renal failure, specifically in the context of renal transplantation. It is being evaluated for its immunoregulatory effects as induction therapy in renal transplant recipients. The drug is currently in early Phase 1 clinical development.

Who makes immunoglobulins?

Immunoglobulins is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this drug for chronic renal failure and renal transplantation. Roche is the sponsor of the ongoing clinical trial for this investigational therapy.

What phase is immunoglobulins in?

Immunoglobulins is in early Phase 1 clinical development. It has completed one trial, which was an early Phase 1 study. The drug is still investigational and has not been approved by regulatory authorities. It is being studied for its potential use in chronic renal failure and renal transplantation.

What clinical trials is immunoglobulins in?

Immunoglobulins has been studied in one clinical trial with the identifier NCT00176059. This trial, titled 'Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients,' was an early Phase 1 study that has been completed. The trial enrolled 50 participants with chronic renal failure undergoing renal transplantation.

How does immunoglobulins work?

Immunoglobulins is being studied for its immunoregulatory effects in renal transplant recipients. The drug is intended to modulate the immune system as induction therapy, potentially helping to prevent rejection in patients with chronic renal failure who receive a kidney transplant. Its mechanism of action is not fully detailed in available information.