Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302835
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
2006-03-14
Brief Title:
Case-Control Study on Analgesics and Nephropathy SAN
Sponsor:
Center for Epidemiology and Health Research Germany
Organization:
Center for Epidemiology and Health Research Germany
Study Overview
Official Title:
Case-Control Study on Analgesics and Nephropathy SAN
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the international multicenter case-control study was to evaluate the association between end-stage renal disease ESRD and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations
Detailed Description:
Background
The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed A new epidemiologic study was planned and conducted in Germany and Austria
Methodsdesign
The objective of the international multicenter case-control study was to evaluate the association between end-stage renal disease ESRD and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations A targeted sample of 1000 new incident dialysis patients aged less than 50 years was planned to recruit between January 1 2001 and December 31 2004 The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible Four control subjects per ESRD case matched by age sex and region were selected from the population living in the region the case came from
Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview A set of aids was introduced to reinforce the memory of study participants
A standardized pre-tested interview questionnaire participants a medical documentation sheet physicians in dialysis centres a logbook for all activities dialysis centres were used to collect the necessary data
Quality management consisted of the standardized procedures re- training and supervision of interviewers regular checks of all incoming data for completeness and plausibility
The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators Also other advisory groups assisted the managing committee of the study All relevant German and Austrian nephrological associations supported the study and the study design was carefully reviewed and approved by the Kidney Foundation of Germany
Discussion
The study is expected to answer the main research question by end 2005 There is however a high potential for various biases that we tried to address with adequate measure One limitation however cannot be overcome The methodologically needed age-limitation of the study will make it not easy to generalize the results to age groups over 50 years It might be suggested to repeat the study for persons over 50 years in 10 years when contamination with phenacetin use early in life is likely to be outgrown
The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed A new epidemiologic study was planned and conducted in Germany and Austria
Methodsdesign
The objective of the international multicenter case-control study was to evaluate the association between end-stage renal disease ESRD and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations A targeted sample of 1000 new incident dialysis patients aged less than 50 years was planned to recruit between January 1 2001 and December 31 2004 The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible Four control subjects per ESRD case matched by age sex and region were selected from the population living in the region the case came from
Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview A set of aids was introduced to reinforce the memory of study participants
A standardized pre-tested interview questionnaire participants a medical documentation sheet physicians in dialysis centres a logbook for all activities dialysis centres were used to collect the necessary data
Quality management consisted of the standardized procedures re- training and supervision of interviewers regular checks of all incoming data for completeness and plausibility
The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators Also other advisory groups assisted the managing committee of the study All relevant German and Austrian nephrological associations supported the study and the study design was carefully reviewed and approved by the Kidney Foundation of Germany
Discussion
The study is expected to answer the main research question by end 2005 There is however a high potential for various biases that we tried to address with adequate measure One limitation however cannot be overcome The methodologically needed age-limitation of the study will make it not easy to generalize the results to age groups over 50 years It might be suggested to repeat the study for persons over 50 years in 10 years when contamination with phenacetin use early in life is likely to be outgrown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None