Case-Control Study on Analgesics and Nephropathy (SAN)

This study has been completed.
Sponsor:
Information provided by:
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00302835
First received: March 14, 2006
Last updated: April 21, 2006
Last verified: April 2006

March 14, 2006
April 21, 2006
January 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00302835 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Case-Control Study on Analgesics and Nephropathy (SAN)
Case-Control Study on Analgesics and Nephropathy (SAN)

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.

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.

Methods/design:

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Not Provided
Not Provided
Kidney Failure, Chronic
Drug: non-phenacetin containing analgesics
Not Provided
Heinemann LA, Garbe E, Lewis M, van der Woude F, Graf H. Case-control study on analgesics and nephropathy (SAN): protocol. BMC Nephrol. 2005 Aug 8;6:9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4200
December 2004
Not Provided

Inclusion Criteria:

  • Cases: Patients under the age of 50 years with new (incident) chronic ESDR during the study period in a given dialysis center.
  • Controls: Healthy persons from the same region the case came from and in the same 5-year age and gender group.

Exclusion Criteria:

  • Patients with acute or remittent renal failure (e.g. after renal transplantation), out of age range, dead before the interview could be done, bad physical or mental condition
Both
up to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00302835
2001_1
Not Provided
Not Provided
Center for Epidemiology and Health Research, Germany
Not Provided
Principal Investigator: Lothar AJ Heinemann, Professor Center for Epidemiology and Health Research
Center for Epidemiology and Health Research, Germany
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP