Kidney TransplantationNCT00427024
Renal Transporters After Renal Transplantation
An observational study of Kidney Transplantation and Host vs Graft Reaction, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Previous studies in animals revealed, that the activity of certain transporters along the nephron is changed with acute rejection after renal transplantation. We intend to investigate underlying mechanisms occurring in man in renal biopsy specimens obtained from patients because of acute rejection of the transplant or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Host vs Graft Reaction
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Feb 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals transplanted with a donor kidney
- individuals with acute transplant rejection
Who cannot join
- pregnancy
- malignant disease
- HIV infection
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Münster
Münster, 48149
Gert Gabriëls, PD Dr. med., 0049-251-83-47676, gabrie@uni-muenster.de
Hermann Pavenstädt, Prof. Dr. med., 0049-83-251-47516, Hermann.Pavenstaedt@ukmuenster.de
About this study
Official title: Study of Renal Transporters and Their Regulators After Renal Transplantation
Previous studies in animals revealed, that the activity of certain transporters along the nephron is changed with acute rejection after renal transplantation. We intend to investigate underlying mechanisms occurring in man in renal biopsy specimens obtained from patients because of acute rejection of the transplant or chronic transplant nephropathy.
Read the detailed description
After renal transplantation, caused by ischemia or rejection, often renal transport processes are disturbed. These dysfunctions which are similar to the Fanconi syndrome as well as renal tubular acidosis occur in the early phase after transplantation. Irreversible injuries develop caused by nephrotoxicity of immunosuppressants and renal transplant artery stenoses. Although this has impact on clinical follow up and prognosis of the transplant, up to now, it still has to be clarified by which mechanisms the tubular transport processes are impaired.
In an animal model, we demonstrated first, that expression of membrane proteins is specifically modulated early after transplantation, indicating that changes in expression and function in these models are not due to general necrosis or apoptosis. Second, our results differ from data obtained after ischemia / reperfusion. Third, the regulatory pattern seems not to be the consequence of a systemic effect. We suppose that changes in expression of transporters and receptors after transplantation and rejection are continuously modulated, which may influence the prognosis of the graft. The data suggest that transplantation with acute rejection leads to ischemia-independent changes in the regulation of transporters along the nephron (Velic A, Gabriëls G, Hirsch JR, Schröter R, Edemir B, Paasche S, Schlatter E. Acute rejection after rat renal transplantation leads to downregulation of Na+ and water channels in the collecting duct. Am J Transplant. 2005, 5: 1276-85. Velic A, Hirsch JR, Bartel J, Thomas R, Schröter R, Stegemann H, Edemir B, August C, Schlatter E, Gabriëls G: Renal transplantation modulates expression and function of receptors and transporters of rat proximal tubules. J Am Soc Nephrol. 2004, 15: 967-77).
By means of microarray analysis we examined the expression of genes after renal transplantation in rats. Of the about 18.000 genes, in the model of acute rejection more than 55% of the genes were changed in their expression compared to controls, while transplantation without rejection only induced a change in expression of 30% of the genes. With rejection, about 50% of these genes were upregulated and about 50 % downregulated.
The regulated genes were classified in different groups. An essential part of the genes upregulated with rejection, as expected, point to a massive immune response. With rejection, a large amount of the genes coding for proteins with transport activity or proteins involved in metabolism are downregulated (e.g. amino acid transport, glucose transport, K+-, Ca++- and phosphate transport, transport of water, pH regulation). It was shown that, with rejection, signal transduction pathways involved in protein catabolism and immune response are upregulated.
By the present study in renal biopsies of about 200 transplanted individuals with acute rejection or chronic transplant nephropathy, we intend to examine the regulation of transport systems and regulatory factors during a period of two years. Our hypothesis is that the activity of transporters along the nephron is changed with renal transplantation, acute rejection reaction, or chronic transplant nephropathy. We intend to investigate underlying mechanisms in renal biopsy specimens obtained from patients because of acute rejection reaction or chronic transplant nephropathy.
The study has been designed to analyze whether the renal transport system factors we found to be differentially regulated in rats are regulated similarly with transplant rejection or transplant nephropathy in man.
The findings obtained by these studies also are indispensable regarding a plain comprehension of the development of tubule dysfunction after renal transplantation in man. The examination of the material serves to explore basic pathophysiological mechanisms with rejection and transplant nephropathy.
Details
Individuals with a renal transplant in whom a renal biopsy is indicated because of clinical reasons will be informed about aims and course of the study as well as potential risks and complications of the biopsy procedure. Then they will be asked to participate.
Should the patient decide for participation, he again will be made aware about potential risks and complications of the biopsy procedure using the official information sheet of the hospital on biopsy procedures and a special information sheet affiliated to the study documents. After reading the information sheets, the patients will be asked to sign the agreement. With the patients´ approval, two specimens of the renal transplant will be obtained. The Patient will be monitored for 24 hours clinically and by blood pressure measurements, urinalysis as well as by ultrasound scanning.
If there are no complaints and the controls are alright, the patient may check out of the hospital but is asked to return for a control examination one week later. At this presentation a physician familiar with the study will examine the patient clinically and by ultrasound. The levels of electrolytes, BUN and serum-creatinine will be detected and a venous blood gas analysis will be performed. In case that regarding the consequences of the biopsy everything is fine, the study is finished for this patient. He will be asked to present again, if new symptoms will arise.
While one part of the specimens obtained for diagnostics will be prepared for the study of gene expression immediately after the biopsy procedure, the other will be transported to the institute of pathology and worked up as usual.
- Conditions
- Kidney Transplantation, Host vs Graft Reaction
- Keywords
- renal transplantation, acute rejection, transport, transporter, acute rejection after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Gert Gabriëls, PD Dr. med., Study chair, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427024
- Sponsor's protocol ID
- NTX + Transport
- Status last verified
- Feb 2007
- First submitted
- 25 Jan 2007
- Last updated
- 6 Feb 2007
- Results posted
- No
Publications
Velic A, Gabriels G, Hirsch JR, Schroter R, Edemir B, Paasche S, Schlatter E. Acute rejection after rat renal transplantation leads to downregulation of NA+ and water channels in the collecting duct. Am J Transplant. 2005 Jun;5(6):1276-85. doi: 10.1111/j.1600-6143.2005.00890.x.
PubMed 15888031Velic A, Hirsch JR, Bartel J, Thomas R, Schroter R, Stegemann H, Edemir B, August C, Schlatter E, Gabriels G. Renal transplantation modulates expression and function of receptors and transporters of rat proximal tubules. J Am Soc Nephrol. 2004 Apr;15(4):967-77. doi: 10.1097/01.asn.0000117287.74203.89.
PubMed 15034099
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Renal Transporters and Their Regulators After Renal Transplantation
- ClinicalTrials.gov ID
- NCT00427024
- Acronym / sponsor ID
- NTX + Transport
- Conditions
- Kidney Transplantation, Host vs Graft Reaction
- Keywords
- renal transplantation, acute rejection, transport, transporter, acute rejection after renal transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Feb 2009
- First posted
- 26 Jan 2007 (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.
Previous studies in animals revealed, that the activity of certain transporters along the nephron is changed with acute rejection after renal transplantation. We intend to investigate underlying mechanisms occurring in man in renal biopsy specimens obtained from patients because of acute rejection of the transplant or chronic transplant nephropathy.
Detailed description
After renal transplantation, caused by ischemia or rejection, often renal transport processes are disturbed. These dysfunctions which are similar to the Fanconi syndrome as well as renal tubular acidosis occur in the early phase after transplantation. Irreversible injuries develop caused by nephrotoxicity of immunosuppressants and renal transplant artery stenoses. Although this has impact on clinical follow up and prognosis of the transplant, up to now, it still has to be clarified by which mechanisms the tubular transport processes are impaired.
In an animal model, we demonstrated first, that expression of membrane proteins is specifically modulated early after transplantation, indicating that changes in expression and function in these models are not due to general necrosis or apoptosis. Second, our results differ from data obtained after ischemia / reperfusion. Third, the regulatory pattern seems not to be the consequence of a systemic effect. We suppose that changes in expression of transporters and receptors after transplantation and rejection are continuously modulated, which may influence the prognosis of the graft. The data suggest that transplantation with acute rejection leads to ischemia-independent changes in the regulation of transporters along the nephron (Velic A, Gabriëls G, Hirsch JR, Schröter R, Edemir B, Paasche S, Schlatter E. Acute rejection after rat renal transplantation leads to downregulation of Na+ and water channels in the collecting duct. Am J Transplant. 2005, 5: 1276-85. Velic A, Hirsch JR, Bartel J, Thomas R, Schröter R, Stegemann H, Edemir B, August C, Schlatter E, Gabriëls G: Renal transplantation modulates expression and function of receptors and transporters of rat proximal tubules. J Am Soc Nephrol. 2004, 15: 967-77).
By means of microarray analysis we examined the expression of genes after renal transplantation in rats. Of the about 18.000 genes, in the model of acute rejection more than 55% of the genes were changed in their expression compared to controls, while transplantation without rejection only induced a change in expression of 30% of the genes. With rejection, about 50% of these genes were upregulated and about 50 % downregulated.
The regulated genes were classified in different groups. An essential part of the genes upregulated with rejection, as expected, point to a massive immune response. With rejection, a large amount of the genes coding for proteins with transport activity or proteins involved in metabolism are downregulated (e.g. amino acid transport, glucose transport, K+-, Ca++- and phosphate transport, transport of water, pH regulation). It was shown that, with rejection, signal transduction pathways involved in protein catabolism and immune response are upregulated.
By the present study in renal biopsies of about 200 transplanted individuals with acute rejection or chronic transplant nephropathy, we intend to examine the regulation of transport systems and regulatory factors during a period of two years. Our hypothesis is that the activity of transporters along the nephron is changed with renal transplantation, acute rejection reaction, or chronic transplant nephropathy. We intend to investigate underlying mechanisms in renal biopsy specimens obtained from patients because of acute rejection reaction or chronic transplant nephropathy.
The study has been designed to analyze whether the renal transport system factors we found to be differentially regulated in rats are regulated similarly with transplant rejection or transplant nephropathy in man.
The findings obtained by these studies also are indispensable regarding a plain comprehension of the development of tubule dysfunction after renal transplantation in man. The examination of the material serves to explore basic pathophysiological mechanisms with rejection and transplant nephropathy.
Details
Individuals with a renal transplant in whom a renal biopsy is indicated because of clinical reasons will be informed about aims and course of the study as well as potential risks and complications of the biopsy procedure. Then they will be asked to participate.
Should the patient decide for participation, he again will be made aware about potential risks and complications of the biopsy procedure using the official information sheet of the hospital on biopsy procedures and a special information sheet affiliated to the study documents. After reading the information sheets, the patients will be asked to sign the agreement. With the patients´ approval, two specimens of the renal transplant will be obtained. The Patient will be monitored for 24 hours clinically and by blood pressure measurements, urinalysis as well as by ultrasound scanning.
If there are no complaints and the controls are alright, the patient may check out of the hospital but is asked to return for a control examination one week later. At this presentation a physician familiar with the study will examine the patient clinically and by ultrasound. The levels of electrolytes, BUN and serum-creatinine will be detected and a venous blood gas analysis will be performed. In case that regarding the consequences of the biopsy everything is fine, the study is finished for this patient. He will be asked to present again, if new symptoms will arise.
While one part of the specimens obtained for diagnostics will be prepared for the study of gene expression immediately after the biopsy procedure, the other will be transported to the institute of pathology and worked up as usual.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals transplanted with a donor kidney
- individuals with acute transplant rejection
Key exclusion criteria (3 listed)
- pregnancy
- malignant disease
- HIV infection
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2007.
- Background: PubMed 15888031Velic A, Gabriels G, Hirsch JR, Schroter R, Edemir B, Paasche S, Schlatter E. Acute rejection after rat renal transplantation leads to downregulation of NA+ and water channels in the collecting duct. Am J Transplant. 2005 Jun;5(6):1276-85. doi: 10.1111/j.1600-6143.2005.00890.x.
- Background: PubMed 15034099Velic A, Hirsch JR, Bartel J, Thomas R, Schroter R, Stegemann H, Edemir B, August C, Schlatter E, Gabriels G. Renal transplantation modulates expression and function of receptors and transporters of rat proximal tubules. J Am Soc Nephrol. 2004 Apr;15(4):967-77. doi: 10.1097/01.asn.0000117287.74203.89.
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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.
Gert Gabriëls, PD Dr. med. study chair
University Hospital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Host vs Graft Reaction, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gert Gabriëls, PD Dr. med. (0049-251-83-47676, gabrie@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427024, which also lists 2 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 6 Feb 2007.