Chronic Renal DiseasePhase 4NCT03682952
Evaluation of Nail Fold Microcirculation in CKD
A Phase 4 study testing Alprostadil Injection and Beraprost sodium tablets in people with Chronic Renal Disease, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
To evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Alprostadil Injection and Beraprost sodium tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 30 Apr 2019
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CKD patients
- Without dialysis
- Blood pressure ≤ 140/90mmHg
Who cannot join
- Polycystic kidney
- Endocrine system disease
- Cardio-cerebrovascular disease
- Rheumatic immune disease
- Peripheral vascular disease
- Hematological diseases
- Respiratory disease
- Infection
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: Evaluation of Nail Fold Microcirculation and Interventional Therapy in Patients With Chronic Renal Failure
To evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy
Read the detailed description
The aim of this study is to study the changes of Nailfold Microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of Nailfold Microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.
- Conditions
- Chronic Renal Disease
- Being tested
- Alprostadil Injection, Beraprost sodium tablets
- Keywords
- Chronic Renal Disease, Nail fold microcirculation, Interventional therapy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil InjectionDrug
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.
Beraprost sodium tabletsDrug
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks ,then they take beraprost sodium tablets 40ug orally three times perday for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients. Receives: Drug: Alprostadil Injection; Drug: Beraprost sodium tablets |
| Anemia control group | No intervention | Anemia patients |
| Control group | No intervention | Healthy person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nailfold microcirculation morphological integral
Nail fold capillary microscopy examination
Measured: Up to three and a half months
Nailfold microcirculation blood flow integral
Nail fold capillary microscopy examination
Measured: Up to three and a half months
Nail fold microcirculation perivascular loop integral
Nail fold capillary microscopy examination
Measured: Up to three and a half months
Secondary outcomes (7)
The content of blood serum creatinine
Intravenous blood sampling
Measured: Up to three and a half months
The content of blood urea nitrogen
Intravenous blood sampling，uronoscopy
Measured: Up to three and a half months
The content of blood cystatin C
Intravenous blood sampling
Measured: Up to three and a half months
eGFR
Intravenous blood sampling
Measured: Up to three and a half months
The content of blood albumin
Intravenous blood sampling
Measured: Up to three and a half months
The quantification of urinary protein
Uronoscopy
Measured: Up to three and a half months
The content of hemoglobin
Intravenous blood sampling
Measured: Up to three and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Feb 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Sun, MD, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682952
- Sponsor's protocol ID
- XYFY2018-KL034-01
- Status last verified
- Jun 2018
- First submitted
- 12 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leunissen KM, van den Berg BW, Cheriex EC, Slaaf DW, Reneman RS, van Hooff JP. Influence of fluid removal during haemodialysis on macro- and skin microcirculation. Haemodynamic pathophysiologic study of fluid removal during haemodialysis. Nephron. 1990;54(2):162-8. doi: 10.1159/000185838.
PubMed 2314527Yuksel S, Pancar Yuksel E, Yenercag M, Soylu K, Zengin H, Gulel O, Meric M, Aydin F, Senturk N, Sahin M. Abnormal nail fold capillaroscopic findings in patients with coronary slow flow phenomenon. Int J Clin Exp Med. 2014 Apr 15;7(4):1052-8. eCollection 2014.
PubMed 24955181Senet P, Fichel F, Baudot N, Gaitz JP, Tribout L, Frances C. [Nail-fold capillaroscopy in dermatology]. Ann Dermatol Venereol. 2014 Jun-Jul;141(6-7):429-37. doi: 10.1016/j.annder.2014.04.120. Epub 2014 Jun 2. French.
PubMed 24951141Yuan SY. [Nail-fold microcirculatory flow in liver cirrhosis: diabetes mellitus and systemic lupus erythematosus]. Zhonghua Yi Xue Za Zhi. 1986 Aug;66(8):473-5, 512. No abstract available. Chinese.
PubMed 3096534Paparde A, Neringa-Martinsone K, Plakane L, Aivars JI. Nail fold capillary diameter changes in acute systemic hypoxia. Microvasc Res. 2014 May;93:30-3. doi: 10.1016/j.mvr.2014.02.013. Epub 2014 Mar 6.
PubMed 24607833Schumann L, Korten G, Holdt B, Holtz M. Microcirculation of the fingernail fold in CAPD patients: preliminary observations. Perit Dial Int. 1996 Jul-Aug;16(4):412-6.
PubMed 8863336Hasegawa K, Pereira BP, Pho RW. The microvasculature of the nail bed, nail matrix, and nail fold of a normal human fingertip. J Hand Surg Am. 2001 Mar;26(2):283-90. doi: 10.1053/jhsu.2001.21519.
PubMed 11279575
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nail Fold Microcirculation and Interventional Therapy in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT03682952
- Acronym / sponsor ID
- XYFY2018-KL034-01
- Conditions
- Chronic Renal Disease
- Keywords
- Chronic Renal Disease, Nail fold microcirculation, Interventional therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 25 Sep 2018 (actual)
- 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 evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy
Detailed description
The aim of this study is to study the changes of Nailfold Microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of Nailfold Microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Alprostadil Injection, Drug: Beraprost sodium tabletsAlprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients. |
| Anemia control group | No intervention | –Anemia patients |
| Control group | No intervention | –Healthy person |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients
- Without dialysis
- Blood pressure ≤ 140/90mmHg
Key exclusion criteria (8 listed)
- Polycystic kidney
- Endocrine system disease
- Cardio-cerebrovascular disease
- Rheumatic immune disease
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprostadil InjectionParticipants are given alprostadil injection 10ug intravenously once a day for 2 weeks. | Drug | Experimental group |
| Beraprost sodium tabletsParticipants are given alprostadil injection 10ug intravenously once a day for 2 weeks ,then they take beraprost sodium tablets 40ug orally three times perday for 3 months. | Drug | Experimental group |
Primary outcome
Nailfold microcirculation morphological integral
Time frame: Up to three and a half months
Nail fold capillary microscopy examination
Nailfold microcirculation blood flow integral
Time frame: Up to three and a half months
Nail fold capillary microscopy examination
Nail fold microcirculation perivascular loop integral
Time frame: Up to three and a half months
Nail fold capillary microscopy examination
7 secondary outcomes
The content of blood serum creatinine
Time frame: Up to three and a half months
The content of blood urea nitrogen
Time frame: Up to three and a half months
The content of blood cystatin C
Time frame: Up to three and a half months
eGFR
Time frame: Up to three and a half months
The content of blood albumin
Time frame: Up to three and a half months
The quantification of urinary protein
Time frame: Up to three and a half months
The content of hemoglobin
Time frame: Up to three and a half months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Background: PubMed 2314527Leunissen KM, van den Berg BW, Cheriex EC, Slaaf DW, Reneman RS, van Hooff JP. Influence of fluid removal during haemodialysis on macro- and skin microcirculation. Haemodynamic pathophysiologic study of fluid removal during haemodialysis. Nephron. 1990;54(2):162-8. doi: 10.1159/000185838.
- Background: PubMed 24955181Yuksel S, Pancar Yuksel E, Yenercag M, Soylu K, Zengin H, Gulel O, Meric M, Aydin F, Senturk N, Sahin M. Abnormal nail fold capillaroscopic findings in patients with coronary slow flow phenomenon. Int J Clin Exp Med. 2014 Apr 15;7(4):1052-8. eCollection 2014.
- Background: PubMed 24951141Senet P, Fichel F, Baudot N, Gaitz JP, Tribout L, Frances C. [Nail-fold capillaroscopy in dermatology]. Ann Dermatol Venereol. 2014 Jun-Jul;141(6-7):429-37. doi: 10.1016/j.annder.2014.04.120. Epub 2014 Jun 2. French.
- Background: PubMed 3096534Yuan SY. [Nail-fold microcirculatory flow in liver cirrhosis: diabetes mellitus and systemic lupus erythematosus]. Zhonghua Yi Xue Za Zhi. 1986 Aug;66(8):473-5, 512. No abstract available. Chinese.
- Background: PubMed 24607833Paparde A, Neringa-Martinsone K, Plakane L, Aivars JI. Nail fold capillary diameter changes in acute systemic hypoxia. Microvasc Res. 2014 May;93:30-3. doi: 10.1016/j.mvr.2014.02.013. Epub 2014 Mar 6.
- Background: PubMed 8863336Schumann L, Korten G, Holdt B, Holtz M. Microcirculation of the fingernail fold in CAPD patients: preliminary observations. Perit Dial Int. 1996 Jul-Aug;16(4):412-6.
- Background: PubMed 11279575Hasegawa K, Pereira BP, Pho RW. The microvasculature of the nail bed, nail matrix, and nail fold of a normal human fingertip. J Hand Surg Am. 2001 Mar;26(2):283-90. doi: 10.1053/jhsu.2001.21519.
- Individual participant dataSharing planned: No
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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.
Dong Sun, MD study director
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprostadil Injection and Beraprost sodium tablets in people with Chronic Renal Disease, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 3 inclusion and 8 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 26 Sep 2018. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nailfold microcirculation morphological integral (time frame: Up to three and a half months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682952, which also lists 7 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 26 Sep 2018.