Cardiovascular DiseasesNCT00005536
Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk African-American populations Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1997to Jun 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk African-American populations
Read the detailed description
BACKGROUND:
Although hypertension is a predisposing factor for end stage renal disease, the underlying hypothesis of this study was that in select African-American families genetic factors predisposed them to develop ESRD in the face of hypertension. An inherited basis for H-ESRD was supported by familial clustering of H-ESRD among African Americans that could not be explained by socioeconomic status, access to medical care, and the prevalence of diabetes and hypertension.
DESIGN NARRATIVE:
DNA samples were collected, identified, and clinically characterized from African-American sib-pairs (and other family members with hypertensive end-stage renal disease). This aspect of the study was based on the fact that Dr. Freedman, the principal investigator, had already developed a unique "family history of end-stage renal disease" database independently funded by the End-Stage Renal Disease Network Six. This registry served as a very large and unique collection of African-American end-stage renal disease patients. He began with a candidate gene approach for linkage to hypertensive end-stage renal disease in his patient samples using a variety of growth factor genes, genes involved in sodium transport and vascular tone, as well as human homologues of rodent genes that had, or were to be identified in the future as contributing to ESRD in that organism. If this initial first pass of candidate genes failed to demonstrate linkage to hypertensive end-stage renal disease, a systematic genome-wide scan was to be performed with available simple sequence length polymorphisms (SSLP) and other polymorphic markers. Hypertensive end-stage renal disease is a condition of enormous clinical and economic importance and identification of associated or causative renal-failure genes would form a genetic basis for the detection of high-risk individuals and assist in development of intervention and treatment strategies to prevent this condition.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1997
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Barry Freedman, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005536
- Sponsor's protocol ID
- 5069
- Other IDs
- R01HL056266
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Price JA, Fossey SC, Sale MM, Brewer CS, Freedman BI, Wuerth JP, Bowden DW. Analysis of the HNF4 alpha gene in Caucasian type II diabetic nephropathic patients. Diabetologia. 2000 Mar;43(3):364-72. doi: 10.1007/s001250050055.
PubMed 10768098Freedman BI, Soucie JM, Chapman A, Krisher J, McClellan WM. Racial variation in autosomal dominant polycystic kidney disease. Am J Kidney Dis. 2000 Jan;35(1):35-9. doi: 10.1016/S0272-6386(00)70298-8.
PubMed 10620541Yu H, Freedman BI, Rich SS, Bowden DW. Human Na+/H+ exchanger genes : identification of polymorphisms by radiation hybrid mapping and analysis of linkage in end-stage renal disease. Hypertension. 2000 Jan;35(1 Pt 1):135-43. doi: 10.1161/01.hyp.35.1.135.
PubMed 10642288Freedman BI, Soucie JM, Stone SM, Pegram S. Familial clustering of end-stage renal disease in blacks with HIV-associated nephropathy. Am J Kidney Dis. 1999 Aug;34(2):254-8. doi: 10.1016/s0272-6386(99)70352-5.
PubMed 10430971Yu H, Sale M, Rich SS, Spray BJ, Roh BH, Bowden DW, Freedman BI. Evaluation of markers on human chromosome 10, including the homologue of the rodent Rf-1 gene, for linkage to ESRD in black patients. Am J Kidney Dis. 1999 Feb;33(2):294-300. doi: 10.1016/s0272-6386(99)70303-3.
PubMed 10023641Yu H, Bowden DW, Spray BJ, Rich SS, Freedman BI. Identification of human plasma kallikrein gene polymorphisms and evaluation of their role in end-stage renal disease. Hypertension. 1998 Apr;31(4):906-11. doi: 10.1161/01.hyp.31.4.906.
PubMed 9535413Ramerstorfer J, Furtmuller R, Vogel E, Huck S, Sieghart W. The point mutation gamma 2F77I changes the potency and efficacy of benzodiazepine site ligands in different GABAA receptor subtypes. Eur J Pharmacol. 2010 Jun 25;636(1-3):18-27. doi: 10.1016/j.ejphar.2010.03.015. Epub 2010 Mar 19.
PubMed 20303942Freedman BI, Yu H, Anderson PJ, Roh BH, Rich SS, Bowden DW. Genetic analysis of nitric oxide and endothelin in end-stage renal disease. Nephrol Dial Transplant. 2000 Nov;15(11):1794-800. doi: 10.1093/ndt/15.11.1794.
PubMed 11071967Yu H, Anderson PJ, Freedman BI, Rich SS, Bowden DW. Genomic structure of the human plasma prekallikrein gene, identification of allelic variants, and analysis in end-stage renal disease. Genomics. 2000 Oct 15;69(2):225-34. doi: 10.1006/geno.2000.6330.
PubMed 11031105Fossey SC, Mychaleckyj JC, Pendleton JK, Snyder JR, Bensen JT, Hirakawa S, Rich SS, Freedman BI, Bowden DW. A high-resolution 6.0-megabase transcript map of the type 2 diabetes susceptibility region on human chromosome 20. Genomics. 2001 Aug;76(1-3):45-57. doi: 10.1006/geno.2001.6584.
PubMed 11549316Freedman BI, Soucie JM, Kenderes B, Krisher J, Garrett LE, Caruana RJ, McClellan WM. Family history of end-stage renal disease does not predict dialytic survival. Am J Kidney Dis. 2001 Sep;38(3):547-52. doi: 10.1053/ajkd.2001.26851.
PubMed 11532687Gitter J, Langefeld CD, Rich SS, Pedley CF, Bowden DW, Freedman BI. Prevalence of nephropathy in black patients with type 2 diabetes mellitus. Am J Nephrol. 2002 Jan-Feb;22(1):35-41. doi: 10.1159/000046672.
PubMed 11919401Fan ZJ, Lackland DT, Kenderes B, Krisher J, Freedman BI. Impact of birth weight on familial aggregation of end-stage renal disease. Am J Nephrol. 2003 Mar-Apr;23(2):117-20. doi: 10.1159/000068037.
PubMed 12481151Freedman BI, Rich SS, Yu H, Roh BH, Bowden DW. Linkage heterogeneity of end-stage renal disease on human chromosome 10. Kidney Int. 2002 Sep;62(3):770-4. doi: 10.1046/j.1523-1755.2002.00534.x.
PubMed 12164858Yu H, Song Q, Freedman BI, Chao J, Chao L, Rich SS, Bowden DW. Association of the tissue kallikrein gene promoter with ESRD and hypertension. Kidney Int. 2002 Mar;61(3):1030-9. doi: 10.1046/j.1523-1755.2002.00198.x.
PubMed 11849458
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)
- ClinicalTrials.gov ID
- NCT00005536
- Acronym / sponsor ID
- 5069
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1997
- Study completion
- Jun 2003 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk African-American populations
Detailed description
BACKGROUND:
Although hypertension is a predisposing factor for end stage renal disease, the underlying hypothesis of this study was that in select African-American families genetic factors predisposed them to develop ESRD in the face of hypertension. An inherited basis for H-ESRD was supported by familial clustering of H-ESRD among African Americans that could not be explained by socioeconomic status, access to medical care, and the prevalence of diabetes and hypertension.
DESIGN NARRATIVE:
DNA samples were collected, identified, and clinically characterized from African-American sib-pairs (and other family members with hypertensive end-stage renal disease). This aspect of the study was based on the fact that Dr. Freedman, the principal investigator, had already developed a unique "family history of end-stage renal disease" database independently funded by the End-Stage Renal Disease Network Six. This registry served as a very large and unique collection of African-American end-stage renal disease patients. He began with a candidate gene approach for linkage to hypertensive end-stage renal disease in his patient samples using a variety of growth factor genes, genes involved in sodium transport and vascular tone, as well as human homologues of rodent genes that had, or were to be identified in the future as contributing to ESRD in that organism. If this initial first pass of candidate genes failed to demonstrate linkage to hypertensive end-stage renal disease, a systematic genome-wide scan was to be performed with available simple sequence length polymorphisms (SSLP) and other polymorphic markers. Hypertensive end-stage renal disease is a condition of enormous clinical and economic importance and identification of associated or causative renal-failure genes would form a genetic basis for the detection of high-risk individuals and assist in development of intervention and treatment strategies to prevent this condition.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 10768098Price JA, Fossey SC, Sale MM, Brewer CS, Freedman BI, Wuerth JP, Bowden DW. Analysis of the HNF4 alpha gene in Caucasian type II diabetic nephropathic patients. Diabetologia. 2000 Mar;43(3):364-72. doi: 10.1007/s001250050055.
- Background: PubMed 10620541Freedman BI, Soucie JM, Chapman A, Krisher J, McClellan WM. Racial variation in autosomal dominant polycystic kidney disease. Am J Kidney Dis. 2000 Jan;35(1):35-9. doi: 10.1016/S0272-6386(00)70298-8.
- Background: PubMed 10642288Yu H, Freedman BI, Rich SS, Bowden DW. Human Na+/H+ exchanger genes : identification of polymorphisms by radiation hybrid mapping and analysis of linkage in end-stage renal disease. Hypertension. 2000 Jan;35(1 Pt 1):135-43. doi: 10.1161/01.hyp.35.1.135.
- Background: PubMed 10430971Freedman BI, Soucie JM, Stone SM, Pegram S. Familial clustering of end-stage renal disease in blacks with HIV-associated nephropathy. Am J Kidney Dis. 1999 Aug;34(2):254-8. doi: 10.1016/s0272-6386(99)70352-5.
- Background: PubMed 10023641Yu H, Sale M, Rich SS, Spray BJ, Roh BH, Bowden DW, Freedman BI. Evaluation of markers on human chromosome 10, including the homologue of the rodent Rf-1 gene, for linkage to ESRD in black patients. Am J Kidney Dis. 1999 Feb;33(2):294-300. doi: 10.1016/s0272-6386(99)70303-3.
- Background: PubMed 9535413Yu H, Bowden DW, Spray BJ, Rich SS, Freedman BI. Identification of human plasma kallikrein gene polymorphisms and evaluation of their role in end-stage renal disease. Hypertension. 1998 Apr;31(4):906-11. doi: 10.1161/01.hyp.31.4.906.
- Background: PubMed 20303942Ramerstorfer J, Furtmuller R, Vogel E, Huck S, Sieghart W. The point mutation gamma 2F77I changes the potency and efficacy of benzodiazepine site ligands in different GABAA receptor subtypes. Eur J Pharmacol. 2010 Jun 25;636(1-3):18-27. doi: 10.1016/j.ejphar.2010.03.015. Epub 2010 Mar 19.
- Background: PubMed 11071967Freedman BI, Yu H, Anderson PJ, Roh BH, Rich SS, Bowden DW. Genetic analysis of nitric oxide and endothelin in end-stage renal disease. Nephrol Dial Transplant. 2000 Nov;15(11):1794-800. doi: 10.1093/ndt/15.11.1794.
- Background: PubMed 11031105Yu H, Anderson PJ, Freedman BI, Rich SS, Bowden DW. Genomic structure of the human plasma prekallikrein gene, identification of allelic variants, and analysis in end-stage renal disease. Genomics. 2000 Oct 15;69(2):225-34. doi: 10.1006/geno.2000.6330.
- Background: PubMed 11549316Fossey SC, Mychaleckyj JC, Pendleton JK, Snyder JR, Bensen JT, Hirakawa S, Rich SS, Freedman BI, Bowden DW. A high-resolution 6.0-megabase transcript map of the type 2 diabetes susceptibility region on human chromosome 20. Genomics. 2001 Aug;76(1-3):45-57. doi: 10.1006/geno.2001.6584.
- Background: PubMed 11532687Freedman BI, Soucie JM, Kenderes B, Krisher J, Garrett LE, Caruana RJ, McClellan WM. Family history of end-stage renal disease does not predict dialytic survival. Am J Kidney Dis. 2001 Sep;38(3):547-52. doi: 10.1053/ajkd.2001.26851.
- Background: PubMed 11919401Gitter J, Langefeld CD, Rich SS, Pedley CF, Bowden DW, Freedman BI. Prevalence of nephropathy in black patients with type 2 diabetes mellitus. Am J Nephrol. 2002 Jan-Feb;22(1):35-41. doi: 10.1159/000046672.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Freedman
Wake Forest University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005536, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.