Tryptophan Metabolism in Kidney Disease | NCT00758537

Studies
Tryptophan Metabolism in Kidney Disease

NCT00758537

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 14, 2009Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease

Interventions

Not provided

Countries

Germany

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

Jul 2009

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 2007

Primary Completion Date

Not provided

Completion Date

Oct 2008

First Submitted Date

Sep 23, 2008

First Submission Date that Met QC Criteria

Sep 23, 2008

First Posted Date

Sep 25, 2008Estimated

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

Jul 13, 2009

Last Update Posted Date

Jul 14, 2009Estimated

Description Module

Brief Summary

Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed under hemodialysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with chronic kidney disease stage 3
patients with chronic kidney disease stage 4
patients with chronic kidney disease stage 5 (ESRD)
Controls (no kidney disease)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Course of plasma tryptophan level and levels of tryptophan metabolites under standard low-flux hemodialysis.		does not apply

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic kidney disease (for > 3months) stages (National Kidney foundation/ADOQI): 3-5

Exclusion Criteria:

Signs of infection or systemic inflammation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

tertiary care academic center, university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petra Reinke, Md PhD	Charite University Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Medicine Berlin		Berlin	State of Berlin	13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided