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NCT01029587 · ClinicalTrials.gov registry record · Phase 2

Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome

A Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome, sponsored by Johns Hopkins University.

Compiled by PlainTrial · August 8, 2026

Completed
Registry status: Phase 2
Development phase: 1
Enrollment target: 1
Study location

NCT01029587: Completed Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome, sponsored by Johns Hopkins University.

NCT01029587 is a Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome that has completed, run by Johns Hopkins University. The registered enrollment target is 1 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01029587, a Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status: Phase 2
Development phase: 1 participants
Enrollment target: 1
Study location

Study Summary

Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death. The causes of CAPS are not entirely understood, but CAPS episodes are often triggered by stressful events such as infections, surgery, or trauma. For patients who survive an episode of CAPS, permanent kidney failure is not uncommon because the kidneys are the organ system most frequently affected in CAPS. Kidney transplantation is the treatment of choice for end-stage kidney disease, but patients with a history of CAPS are exceptionally high-risk kidney transplant recipients because the chance that surgery itself could trigger a life-threatening or transplant-threatening episode of CAPS is significant. As a result, patients with CAPS are not generally considered candidates for transplantation. Despite this, these patients have a severely decreased life-expectancy on dialysis and their long-term survival and quality of life would be greatly increased by a successful kidney transplant. In this trial, a drug called eculizumab will be tested for its ability to prevent CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an inhibitor of the complement system, which is believed to be important in generating the inflammatory environment that leads to diffuse clotting of blood vessels in CAPS. The investigators hypothesize that by blocking the complement cascade using eculizumab, in conjunction with blocking the coagulation system, that kidney transplantation can be safely and successfully performed in patients with a history of CAPS.

Conditions Studied

End Stage Renal Disease Antiphospholipid Antibody Syndrome

Interventions

DRUG Eculizumab

Study Locations (1)

Maryland

Johns Hopkins University School of Medicine - Baltimore

Trial Details

Field	Value
Enrollment Target	1 participants
Start Date	2009-11
Est. Completion	2010-05-06
Phase	Phase 2

Johns Hopkins University

1,448 total trials

What the finished NCT01029587 record still lists

NCT01029587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Eculizumab is the first listed.

NCT01029587 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01029587 about?

NCT01029587 is a clinical study titled "Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome". Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death. The causes of CAPS are not entirely understood, but CAPS episodes are often triggered by stres...

What is the current status of trial NCT01029587?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-11. Estimated completion is 2010-05-06.

What conditions does trial NCT01029587 study?

This clinical trial studies the following conditions: End Stage Renal Disease, Antiphospholipid Antibody Syndrome.

What interventions are being tested in trial NCT01029587?

The interventions under investigation include: Eculizumab (DRUG).

Who is sponsoring clinical trial NCT01029587?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01029587 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01029587's enrollment target sits among peer trials

1 87th of 86 the lowest of 86 other End Stage Renal Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01029587, the US trial registry maintained by the National Library of Medicine. NCT01029587 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.