Neocytolysis in the Treatment of Renal Anemia With Erythr... | NCT01306409

Studies
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

NCT01306409

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Oct 19, 2011Estimated

Enrollment

9Actual

Phase

Phase 4

Conditions

Renal Anemia

Interventions

cera, darbepoetin, epoetin-beta
ESA

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Feb 28, 2011

First Posted Date

Mar 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2011

Last Update Posted Date

Oct 19, 2011Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Sequential application of different ESA	Drug: cera, darbepoetin, epoetin-beta Drug: ESA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cera, darbepoetin, epoetin-beta	Drug	Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk	A

Measure	Description	Time Frame
Reticulocyte count on day 7		day 7

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed informed consent
age > 18 years, dialysis dependent chronic renal failure
hemodialysis three times a week
Kt/V > 1,2 od URR > 65%
hemoglobin between 11 and 13 g/dl within the last 2 months
hemoglobin change +/- 1g/dl within the last 4 weeks
ESA for at least 8 weeks
Ferritin > 300 ng/ml and Tsat > 25%

Exclusion Criteria:

Significant bleeding in the last 8 weeks
blood transfusion within the last 8 weeks
hemoglobin disorder
hemolysis
Malignant disease
Significant inflammation
Acute infection
CRP > 30 mg/l
Temporary vascular dialysis access
Vitamin B12 deficiency
Folic acid deficiency
Not controlled hyperparathyroidism
Not controlled hypertension
Epilepsia within thze last 6 months
Thrombocyte count > 500 x 10^9 /l

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Dickenmann, MD	Transplantation immunology and nephrology, unversity hospital Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nephrology and Transplantaton Immunology		Basel	Canton of Basel-City	4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36791280	Derived	Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

ID	Term
D000740	Anemia
D007674	Kidney Diseases

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
C508420	continuous erythropoietin receptor activator
D000068256	Darbepoetin alfa
C103998	epoetin beta

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates